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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
20/12/2019 Minutes: Minutes of the CHMP meeting 14-17 October 2019
20/12/2019 Other: Outcome of written procedures finalised during the period from 17 September 2019 to 22 November 2019
20/12/2019 Report: Summary of transfers of appropriations and Summary report on implementation of assigned revenue, fund sources R0 & CL, in budget 2019
20/12/2019 Other: Financial Regulation applicable to the budget of the European Medicines Agency from 1 July 2019
20/12/2019 Agenda: Agenda for the 106th meeting of the Management Board: 18-19 December 2019
20/12/2019 Other: Decision of the Executive Director On rules governing the secondment of national experts to the EMA
20/12/2019 Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan, lopinavir/ritonavir, HIV Infections, 14/01/2016, Generic, 8, Authorised
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
20/12/2019 Human medicines European public assessment report (EPAR): Darunavir Mylan, darunavir, HIV Infections, 03/01/2017, Generic, 6, Authorised
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
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
20/12/2019 Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Skin Diseases, Bacterial, 16/12/2019, Additional monitoring, Authorised
20/12/2019 Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 17/07/2014, 18, Authorised
20/12/2019 Human medicines European public assessment report (EPAR): Levitra, vardenafil, Erectile Dysfunction, 06/03/2003, 30, Authorised
20/12/2019 Q&A: Transfer
20/12/2019 Q&A: 21-39
20/12/2019 Human medicines European public assessment report (EPAR): Synjardy, empagliflozin, metformin, Diabetes Mellitus, Type 2, 27/05/2015, Additional monitoring, 15, Authorised
20/12/2019 Other: EMA tracking tool: relocation to Amsterdam - Main milestones
20/12/2019 Availability of medicines
20/12/2019 Minutes: Minutes of the CVMP meeting of 8-10 October 2019
20/12/2019 Minutes: Minutes of the CVMP meeting of 5-7 November 2019
20/12/2019 News and press releases: EMA Management Board: highlights of December 2019 meeting
20/12/2019 Q&A: Post-authorisation measures (recommendations, conditions and specific obligations)
20/12/2019 Q&A: Renewals
20/12/2019 Q&A: Worksharing of variations
20/12/2019 Human medicines European public assessment report (EPAR): Kolbam , cholic acid, Metabolism, Inborn Errors, 20/11/2015, Orphan, Additional monitoring, Exceptional circumstances, 13, Authorised
20/12/2019 Q&A: Grouping of variations
20/12/2019 Q&A: Extension applications
20/12/2019 Human medicines European public assessment report (EPAR): Gilenya, fingolimod hydrochloride , Multiple Sclerosis, 17/03/2011, Patient safety, Additional monitoring, 24, Authorised
20/12/2019 Human medicines European public assessment report (EPAR): Vivanza, vardenafil, Erectile Dysfunction, 04/03/2003, 26, Authorised
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
19/12/2019 Minutes: Minutes of the COMP meeting 16-18 July 2019
19/12/2019 Minutes: Minutes of the PRAC meeting 8-11 July 2019
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
19/12/2019 Deputy Executive Director and support services
19/12/2019 Other: Organisation chart: Deputy Executive Director support services
19/12/2019 Other: Privacy statement on the processing of personal data in the context of administrative inquiries and disciplinary proceedings
19/12/2019 Human medicines European public assessment report (EPAR): Brinavess, Vernakalant hydrochloride, Atrial Fibrillation, 01/09/2010, 14, Authorised
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
19/12/2019 Minutes: Meeting summary - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations
19/12/2019 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-20 November 2019
19/12/2019 Human medicines European public assessment report (EPAR): Spravato, esketamine hydrochloride, Depressive Disorder, 18/12/2019, Additional monitoring, Authorised
19/12/2019 Human medicines European public assessment report (EPAR): Comtan, entacapone, Parkinson Disease, 22/09/1998, 24, Authorised
19/12/2019 Alectinib product-specific bioequivalence guidance
19/12/2019 Human medicines European public assessment report (EPAR): Emend, Aprepitant, Vomiting, Postoperative Nausea and Vomiting, Cancer, 11/11/2003, 25, Authorised
19/12/2019 Other: Orientation guide for industry - EMA building
19/12/2019 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 9-12 December 2019
19/12/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba
19/12/2019 Herbal medicinal product: Herniariae herba, Herniariae herba, D: Draft under discussion
19/12/2019 Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V., lamivudine, HIV Infections, 10/12/2009, Generic, 14, Authorised
19/12/2019 Human medicines European public assessment report (EPAR): Cetrotide, cetrorelix, Ovulation, Ovulation Induction, 12/04/1999, 26, Authorised
19/12/2019 Human medicines European public assessment report (EPAR): Betaferon, interferon beta-1b, Multiple Sclerosis, 30/11/1995, 32, Authorised
19/12/2019 Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Multiple Sclerosis, 13/03/1997, 32, Authorised
18/12/2019 Periodic safety update reports (PSURs)
18/12/2019 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 14, Authorised
18/12/2019 Human medicines European public assessment report (EPAR): Rubraca, rucaparib camsylate, Ovarian Neoplasms, 23/05/2018, Additional monitoring, Conditional approval, 3, Authorised
18/12/2019 Signal management
18/12/2019 Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, micronised, Pulmonary Disease, Chronic Obstructive, 20/07/2012, Additional monitoring, 16, Authorised
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
18/12/2019 News and press releases: European Medicines Agency closed 21 December 2019 to 5 January 2020
18/12/2019 Human medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, micronised, Pulmonary Disease, Chronic Obstructive, 20/07/2012, Additional monitoring, 16, Authorised
17/12/2019 International collaboration on GMP inspections
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
17/12/2019 News and press releases: Launch of international pilot programme on inspection of manufacturers of sterile medicines
17/12/2019 Implementation of the pharmacovigilance legislation
17/12/2019 News and press releases: 4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system
17/12/2019 Report: Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2015-2018
17/12/2019 Grouping of variations: questions and answers
17/12/2019 Type-II variations: questions and answers
17/12/2019 Classification of changes: questions and answers
17/12/2019 Renewal and annual re-assessment of marketing authorisation
17/12/2019 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes
17/12/2019 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
17/12/2019 Veterinary medicines European public assessment report (EPAR): Porcilis PCV M Hyo, Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated, 06/11/2014, 5, Authorised
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
16/12/2019 Human medicines European public assessment report (EPAR): Fampyra, Fampridine, Multiple Sclerosis, 20/07/2011, 13, Authorised
16/12/2019 Veterinary medicines European public assessment report (EPAR): Exzolt, fluralaner, 18/08/2017, 1, Authorised
16/12/2019 Human medicines European public assessment report (EPAR): Cinqaero, Reslizumab, Asthma, 15/08/2016, Additional monitoring, 9, Authorised
13/12/2019 How to find us
13/12/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: December 2019
13/12/2019 Recommendation on medication errors: EMA issues alert on the risk of dosing errors with the cancer medicine Trisenox
13/12/2019 Work programme: CVMP work plan 2020
13/12/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019
13/12/2019 Report: Medicinal products for human use: monthly figures - November 2019
13/12/2019 Other: Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)
13/12/2019 Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)
13/12/2019 VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV
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
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, Additional monitoring, Conditional approval, Authorised
12/12/2019 Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Anxiety Disorders, Epilepsy, 10/04/2014, 17, Authorised
12/12/2019 Medicines under additional monitoring: Annex IV - List of thiocolchicoside-containing medicinal products in the European Union
12/12/2019 Medicines under additional monitoring: Annex IV - List of thiocolchicoside-containing medicinal products in the European Union
11/12/2019 Human medicines European public assessment report (EPAR): Simbrinza, brinzolamide, brimonidine tartrate, Ocular Hypertension, Glaucoma, Open-Angle, 18/07/2014, 7, Authorised
11/12/2019 News and press releases: Six-year review shows success of the EU signal management system in improving safe use of medicines
11/12/2019 Human medicines European public assessment report (EPAR): Entresto, sacubitril, valsartan, Heart Failure, 19/11/2015, Additional monitoring, 9, Authorised
11/12/2019 Management Board meeting: 3 October 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 03/10/2019 to 03/10/2019
11/12/2019 Minutes: Minutes of the 105th meeting of the Management Board: 3 October 2019
11/12/2019 Referrals document: Fluorouracil and fluorouracil related substances Article 31 referral - Timetable for the procedure
11/12/2019 Human medicines European public assessment report (EPAR): Visudyne, verteporfin, Myopia, Degenerative, Macular Degeneration, 27/07/2000, 34, Authorised
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)
11/12/2019 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 24, Authorised
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
11/12/2019 Good pharmacovigilance practices
11/12/2019 Scientific guideline: Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women
10/12/2019 Veterinary medicines European public assessment report (EPAR): Gumbohatch, live attenuated infectious bursal disease virus (IBDV), strain 1052, 12/11/2019, Authorised
10/12/2019 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, Additional monitoring, 8, Authorised
10/12/2019 Other: Guide on access to unpublished documents
10/12/2019 Other: Open call for data on use of antimicrobials in animals
10/12/2019 News and press releases: How will pharmacovigilance look in 2030?
10/12/2019 Newsletter: Human medicines highlights - December 2019
10/12/2019 Human medicines European public assessment report (EPAR): Irbesartan Teva, irbesartan, Hypertension, 30/10/2009, Generic, 12, Authorised
10/12/2019 Agenda: Agenda - PDCO agenda of the 9-11 December 2019 meeting
10/12/2019 Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors
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
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
09/12/2019 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 26/03/2013, Additional monitoring, Conditional approval, 19, Authorised
09/12/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2019
09/12/2019 Advanced therapy classification
09/12/2019 Agenda: Agenda - CHMP agenda of the 9-12 December 2019 meeting
09/12/2019 Human medicines European public assessment report (EPAR): Raxone, idebenone, Optic Atrophy, Hereditary, Leber, 08/09/2015, Orphan, Additional monitoring, Exceptional circumstances, 5, Authorised
09/12/2019 Herbal medicinal product: Hamamelidis folium, Hamamelidis folium, F: Assessment finalised
09/12/2019 Herbal - HMPC assessment report: Addendum to assessment report on Hamamelis virginiana L., folium
09/12/2019 Herbal medicinal product: Tormentillae rhizoma, Tormentillae rhizoma, C: ongoing call for scientific data
06/12/2019 Human medicines European public assessment report (EPAR): Intrarosa, Prasterone, Postmenopause, 08/01/2018, Additional monitoring, 4, Authorised
06/12/2019 Other: European Medicines Agency’s privacy statement concerning requests for information or access to documents
06/12/2019 Summary of opinion: Velactis, cabergoline, 05/12/2019, Negative
06/12/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 2019
06/12/2019 News and press releases: EMA update on metformin diabetes medicines
06/12/2019 Other: Expected publication dates of PRAC recommendations on safety signals
06/12/2019 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 38, Authorised
05/12/2019 Agenda: Agenda - CAT agenda of the 4-6 December 2019 meeting
05/12/2019 Periodic safety update single assessment: Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904
05/12/2019 Periodic safety update single assessment: Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201904
05/12/2019 Report: Applications for new human medicines under evaluation by the CHMP: December 2019
05/12/2019 Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures
05/12/2019 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 23, Authorised
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
05/12/2019 Authorisation of medicines
05/12/2019 What we do
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, Exceptional circumstances, 9, Authorised
04/12/2019 Herbal medicinal product: Hamamelidis cortex, Hamamelidis cortex, F: Assessment finalised
04/12/2019 Human medicines European public assessment report (EPAR): Stayveer, bosentan monohydrate, Hypertension, Pulmonary, Scleroderma, Systemic, 24/06/2013, 11, Authorised
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
04/12/2019 Orphan designation: Ivosidenib for the: Treatment of acute myeloid leukaemia, 12/12/2016, Positive
04/12/2019 Agenda: Agenda - CVMP agenda of the 3-5 December 2019 meeting
04/12/2019 Herbal medicinal product: Hamamelidis folium et cortex aut ramunculus destillatum, Hamamelidis folium et cortex aut ramunculus destillatum, F: Assessment finalised
04/12/2019 Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised
04/12/2019 Herbal – European Union herbal monograph: Final community herbal monograph on Hamamelis virginiana L., cortex
03/12/2019 Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, 13/02/2017, Additional monitoring, 6, Authorised
03/12/2019 Other: PRAC meetings in 2019, 2020, 2021
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
03/12/2019 Report: Social Media and M-Health Data - Subgroup report
03/12/2019 Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors, 17/09/2017, Orphan, Additional monitoring, 8, Authorised
03/12/2019 Agenda: Agenda - COMP agenda of the 03-05 December 2019 meeting
03/12/2019 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 40, Authorised
03/12/2019 Periodic safety update single assessment: Carteolol: List of nationally authorised medicinal products - PSUSA/00000574/201903
03/12/2019 Human medicines European public assessment report (EPAR): Rhokiinsa, Netarsudil, Glaucoma, Open-Angle, Ocular Hypertension, 19/11/2019, Additional monitoring, Authorised
03/12/2019 Orphan designation: Vatiquinone for the: Treatment of RARS2 syndrome, 17/01/2018, Positive
03/12/2019 Orphan designation: (R)-troloxamide quinone for the: Treatment of amyotrophic lateral sclerosis, 12/10/2017, Positive
03/12/2019 Orphan designation: Alpha-tocotrienol quinone for the: Treatment of Leigh syndrome, 09/12/2011, Positive
03/12/2019 EPAR - All authorised presentations: Synagis : EPAR - All Authorised presentations
02/12/2019 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 39, Authorised
02/12/2019 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, Additional monitoring, 7, Authorised
02/12/2019 Periodic safety update single assessment: Carvedilol / ivabradine : List of nationally authorised medicinal products - PSUSA/00010586/201904
02/12/2019 Periodic safety update single assessment: Varicella vaccine (live) : List of nationally authorised medicinal products - PSUSA/000010473/201903
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
02/12/2019 Other: HMPC meetings in 2019, 2020 and 2021
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
02/12/2019 Orphan designation: S-acetyl-(S)-4'-phosphopantetheine, calcium salt for the: Treatment of pantothenate-kinase-associated neurodegeneration, 28/04/2016, Positive
02/12/2019 Periodic safety update single assessment: Nefopam: List of nationally authorised medicinal products - PSUSA/00002131/201903
02/12/2019 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, Additional monitoring, 15, Authorised