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20/12/2019 |
Committee for Medicinal Products for Human Use (CHMP): 14-17 October 2019
, European Medicines Agency, Amsterdam, the Netherlands, from 14/10/2019 to 17/10/2019 |
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20/12/2019 |
Minutes: Minutes of the CHMP meeting 14-17 October 2019
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20/12/2019 |
Other: Outcome of written procedures finalised during the period from 17 September 2019 to 22 November 2019
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20/12/2019 |
Report: Summary of transfers of appropriations and Summary report on implementation of assigned revenue, fund sources R0 & CL, in budget 2019
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20/12/2019 |
Other: Financial Regulation applicable to the budget of the European Medicines Agency from 1 July 2019
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20/12/2019 |
Agenda: Agenda for the 106th meeting of the Management Board: 18-19 December 2019
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20/12/2019 |
Other: Decision of the Executive Director On rules governing the secondment of national experts to the EMA
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20/12/2019 |
Human medicines European public assessment report (EPAR): Kiovig, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 18/01/2006, 24, Authorised |
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20/12/2019 |
Human medicines European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop), docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 20/04/2007, 30, Authorised |
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20/12/2019 |
Human medicines European public assessment report (EPAR): Mircera, Methoxy polyethylene glycol-epoetin beta, Anemia, Kidney Failure, Chronic, 20/07/2007, 25, Authorised |
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20/12/2019 |
Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 17/07/2014, 18, Authorised |
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20/12/2019 |
Q&A: Transfer |
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20/12/2019 |
Q&A: 21-39 |
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20/12/2019 |
Minutes: Minutes of the CVMP meeting of 8-10 October 2019
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20/12/2019 |
Minutes: Minutes of the CVMP meeting of 5-7 November 2019
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20/12/2019 |
News and press releases: EMA Management Board: highlights of December 2019 meeting |
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20/12/2019 |
Q&A: Post-authorisation measures (recommendations, conditions and specific obligations) |
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20/12/2019 |
Q&A: Renewals |
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20/12/2019 |
Q&A: Worksharing of variations |
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20/12/2019 |
Q&A: Grouping of variations |
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20/12/2019 |
Q&A: Extension applications |
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20/12/2019 |
Human medicines European public assessment report (EPAR): Gilenya, fingolimod hydrochloride , Multiple Sclerosis, 17/03/2011,  ,  , 24, Authorised |
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19/12/2019 |
Committee for Orphan Medicinal Products (COMP): 16-18 July 2019
, European Medicines Agency, Amsterdam, the Netherlands, from 16/07/2019 to 18/07/2019 |
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19/12/2019 |
Minutes: Minutes of the COMP meeting 16-18 July 2019
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19/12/2019 |
Minutes: Minutes of the PRAC meeting 8-11 July 2019
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19/12/2019 |
Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2019
, European Medicines Agency, Amsterdam, the Netherlands, from 08/07/2019 to 11/07/2019 |
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19/12/2019 |
Deputy Executive Director and support services |
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19/12/2019 |
Other: Organisation chart: Deputy Executive Director support services
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19/12/2019 |
Other: Privacy statement on the processing of personal data in the context of administrative inquiries and disciplinary proceedings
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19/12/2019 |
Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations
, European Medicines Agency, Amsterdam, the Netherlands, from 20/11/2019 to 20/11/2019 |
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19/12/2019 |
Minutes: Meeting summary - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations
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19/12/2019 |
Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-20 November 2019
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19/12/2019 |
Human medicines European public assessment report (EPAR): Spravato, esketamine hydrochloride, Depressive Disorder, 18/12/2019, , Authorised |
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19/12/2019 |
Human medicines European public assessment report (EPAR): Comtan, entacapone, Parkinson Disease, 22/09/1998, 24, Authorised |
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19/12/2019 |
Alectinib product-specific bioequivalence guidance |
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19/12/2019 |
Human medicines European public assessment report (EPAR): Emend, Aprepitant, Vomiting, Postoperative Nausea and Vomiting, Cancer, 11/11/2003, 25, Authorised |
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19/12/2019 |
Other: Orientation guide for industry - EMA building
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19/12/2019 |
Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 9-12 December 2019
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19/12/2019 |
Herbal – European Union herbal monograph: Draft European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba
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19/12/2019 |
Human medicines European public assessment report (EPAR): Cetrotide, cetrorelix, Ovulation, Ovulation Induction, 12/04/1999, 26, Authorised |
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19/12/2019 |
Human medicines European public assessment report (EPAR): Betaferon, interferon beta-1b, Multiple Sclerosis, 30/11/1995, 32, Authorised |
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19/12/2019 |
Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Multiple Sclerosis, 13/03/1997, 32, Authorised |
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18/12/2019 |
Signal management |
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18/12/2019 |
Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, micronised, Pulmonary Disease, Chronic Obstructive, 20/07/2012, , 16, Authorised |
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18/12/2019 |
Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (niraparib)
for the: Treatment of ovarian cancer, 04/08/2010, Positive |
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18/12/2019 |
News and press releases: European Medicines Agency closed 21 December 2019 to 5 January 2020 |
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18/12/2019 |
Human medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, micronised, Pulmonary Disease, Chronic Obstructive, 20/07/2012, , 16, Authorised |
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17/12/2019 |
International collaboration on GMP inspections |
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17/12/2019 |
Other: Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use - Terms of reference for participating authorities
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17/12/2019 |
News and press releases: Launch of international pilot programme on inspection of manufacturers of sterile medicines |
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17/12/2019 |
Implementation of the pharmacovigilance legislation |
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17/12/2019 |
News and press releases: 4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system |
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17/12/2019 |
Report: Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2015-2018
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17/12/2019 |
Classification of changes: questions and answers |
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16/12/2019 |
Veterinary medicines European public assessment report (EPAR): Nobivac Myxo-RHD Plus, Live myxoma vectored RHD virus strain 009, Live myxoma vectored RHD virus strain MK1899, 19/11/2019, Authorised |
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16/12/2019 |
Human medicines European public assessment report (EPAR): Fampyra, Fampridine, Multiple Sclerosis, 20/07/2011, 13, Authorised |
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16/12/2019 |
Veterinary medicines European public assessment report (EPAR): Exzolt, fluralaner, 18/08/2017, 1, Authorised |
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16/12/2019 |
Human medicines European public assessment report (EPAR): Cinqaero, Reslizumab, Asthma, 15/08/2016, , 9, Authorised |
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13/12/2019 |
How to find us |
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13/12/2019 |
Committee meeting report: COMP meeting report on the review of applications for orphan designation: December 2019
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13/12/2019 |
Recommendation on medication errors: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox
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13/12/2019 |
Work programme: CVMP work plan 2020
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13/12/2019 |
News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019 |
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13/12/2019 |
Report: Medicinal products for human use: monthly figures - November 2019
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13/12/2019 |
Other: Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)
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13/12/2019 |
Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP) |
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13/12/2019 |
VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV |
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13/12/2019 |
Scientific guideline: VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version
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12/12/2019 |
Human medicines European public assessment report (EPAR): Ervebo, recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola, 11/11/2019, ,  , Authorised |
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12/12/2019 |
Medicines under additional monitoring: Annex IV - List of thiocolchicoside-containing medicinal products in the European Union
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12/12/2019 |
Medicines under additional monitoring: Annex IV - List of thiocolchicoside-containing medicinal products in the European Union
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11/12/2019 |
News and press releases: Six-year review shows success of the EU signal management system in improving safe use of medicines |
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11/12/2019 |
Human medicines European public assessment report (EPAR): Entresto, sacubitril, valsartan, Heart Failure, 19/11/2015, , 9, Authorised |
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11/12/2019 |
Management Board meeting: 3 October 2019
, European Medicines Agency, Amsterdam, the Netherlands, from 03/10/2019 to 03/10/2019 |
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11/12/2019 |
Minutes: Minutes of the 105th meeting of the Management Board: 3 October 2019
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11/12/2019 |
Referrals document: Fluorouracil and fluorouracil related substances Article 31 referral - Timetable for the procedure
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11/12/2019 |
Human medicines European public assessment report (EPAR): Visudyne, verteporfin, Myopia, Degenerative, Macular Degeneration, 27/07/2000, 34, Authorised |
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11/12/2019 |
Report: Annual report 2018 on staff engaging in an occupational activity within two years of leaving the service (article 16 of the staff regulations)
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11/12/2019 |
Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women
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11/12/2019 |
Good pharmacovigilance practices |
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11/12/2019 |
Scientific guideline: Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women
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10/12/2019 |
Veterinary medicines European public assessment report (EPAR): Gumbohatch, live attenuated infectious bursal disease virus (IBDV), strain 1052, 12/11/2019, Authorised |
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10/12/2019 |
Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, , 8, Authorised |
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10/12/2019 |
Other: Guide on access to unpublished documents
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10/12/2019 |
Other: Open call for data on use of antimicrobials in animals
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10/12/2019 |
News and press releases: How will pharmacovigilance look in 2030? |
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10/12/2019 |
Newsletter: Human medicines highlights - December 2019
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10/12/2019 |
Human medicines European public assessment report (EPAR): Irbesartan Teva, irbesartan, Hypertension, 30/10/2009,  , 12, Authorised |
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10/12/2019 |
Agenda: Agenda - PDCO agenda of the 9-11 December 2019 meeting
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09/12/2019 |
Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for veterinary medicines)
, European Medicines Agency, Amsterdam, the Netherlands, from 05/12/2019 to 06/12/2019 |
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09/12/2019 |
Committee for Medicinal Products for Veterinary Use (CVMP): 08-10 October 2019
, European Medicines Agency, Amsterdam, the Netherlands, from 08/10/2019 to 10/10/2019 |
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09/12/2019 |
Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 26/03/2013, , , 19, Authorised |
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09/12/2019 |
Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2019
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09/12/2019 |
Advanced therapy classification |
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09/12/2019 |
Agenda: Agenda - CHMP agenda of the 9-12 December 2019 meeting
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09/12/2019 |
Human medicines European public assessment report (EPAR): Raxone, idebenone, Optic Atrophy, Hereditary, Leber, 08/09/2015,  , ,  , 5, Authorised |
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09/12/2019 |
Herbal medicinal product: Hamamelidis folium, Hamamelidis folium, F: Assessment finalised
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09/12/2019 |
Herbal - HMPC assessment report: Addendum to assessment report on Hamamelis virginiana L., folium
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06/12/2019 |
Human medicines European public assessment report (EPAR): Intrarosa, Prasterone, Postmenopause, 08/01/2018, , 4, Authorised |
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06/12/2019 |
Summary of opinion: Velactis, cabergoline, 05/12/2019, Negative |
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06/12/2019 |
News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 2019 |
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06/12/2019 |
News and press releases: EMA update on metformin diabetes medicines |
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06/12/2019 |
Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 38, Authorised |
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05/12/2019 |
Agenda: Agenda - CAT agenda of the 4-6 December 2019 meeting
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05/12/2019 |
Periodic safety update single assessment: Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904
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05/12/2019 |
Periodic safety update single assessment: Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201904
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05/12/2019 |
Report: Applications for new human medicines under evaluation by the CHMP: December 2019
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05/12/2019 |
Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures
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05/12/2019 |
Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 23, Authorised |
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05/12/2019 |
Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab)
for the: Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive |
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05/12/2019 |
Authorisation of medicines |
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05/12/2019 |
What we do |
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04/12/2019 |
Human medicines European public assessment report (EPAR): Foclivia, influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 18/10/2009, , 9, Authorised |
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04/12/2019 |
Herbal medicinal product: Hamamelidis cortex, Hamamelidis cortex, F: Assessment finalised
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04/12/2019 |
Orphan designation: 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl
for the: Treatment of familial cerebral cavernous malformations, 12/12/2017, Positive |
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04/12/2019 |
Orphan designation: Ivosidenib
for the: Treatment of acute myeloid leukaemia, 12/12/2016, Positive |
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04/12/2019 |
Agenda: Agenda - CVMP agenda of the 3-5 December 2019 meeting
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04/12/2019 |
Herbal medicinal product: Hamamelidis folium et cortex aut ramunculus destillatum, Hamamelidis folium et cortex aut ramunculus destillatum, F: Assessment finalised
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04/12/2019 |
Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
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04/12/2019 |
Herbal – European Union herbal monograph: Final community herbal monograph on Hamamelis virginiana L., cortex
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03/12/2019 |
Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, 13/02/2017, , 6, Authorised |
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03/12/2019 |
Other: PRAC meetings in 2019, 2020, 2021
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03/12/2019 |
PRAC recommendation on signal: Updated signal assessment report on birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications with ondansetr
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03/12/2019 |
Report: Social Media and M-Health Data - Subgroup report
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03/12/2019 |
Agenda: Agenda - COMP agenda of the 03-05 December 2019 meeting
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03/12/2019 |
Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 40, Authorised |
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03/12/2019 |
Periodic safety update single assessment: Carteolol: List of nationally authorised medicinal products - PSUSA/00000574/201903
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03/12/2019 |
Human medicines European public assessment report (EPAR): Rhokiinsa, Netarsudil, Glaucoma, Open-Angle, Ocular Hypertension, 19/11/2019, , Authorised |
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03/12/2019 |
Orphan designation: Vatiquinone
for the: Treatment of RARS2 syndrome, 17/01/2018, Positive |
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03/12/2019 |
Orphan designation: (R)-troloxamide quinone
for the: Treatment of amyotrophic lateral sclerosis, 12/10/2017, Positive |
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03/12/2019 |
Orphan designation: Alpha-tocotrienol quinone
for the: Treatment of Leigh syndrome, 09/12/2011, Positive |
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03/12/2019 |
EPAR - All authorised presentations: Synagis : EPAR - All Authorised presentations
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02/12/2019 |
Periodic safety update single assessment: Carvedilol / ivabradine : List of nationally authorised medicinal products - PSUSA/00010586/201904
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02/12/2019 |
Periodic safety update single assessment: Varicella vaccine (live) : List of nationally authorised medicinal products - PSUSA/000010473/201903
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02/12/2019 |
Paediatric strategy forum for medicinal product development for acute myeloid leukaemia in children and adolescents
, Rotterdam, Netherlands, from 02/12/2019 to 02/12/2019 |
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02/12/2019 |
Other: HMPC meetings in 2019, 2020 and 2021
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02/12/2019 |
Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients
, European Medicines Agency, London, UK, from 05/09/2018 to 06/09/2018 |
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02/12/2019 |
Orphan designation: S-acetyl-(S)-4'-phosphopantetheine, calcium salt
for the: Treatment of pantothenate-kinase-associated neurodegeneration, 28/04/2016, Positive |
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02/12/2019 |
Periodic safety update single assessment: Nefopam: List of nationally authorised medicinal products - PSUSA/00002131/201903
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02/12/2019 |
Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, , 15, Authorised |
