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06/12/2019 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, Additional monitoring, 7, Authorised (updated)
06/12/2019 Human medicines European public assessment report (EPAR): Intrarosa, Prasterone, Menopause, 08/01/2018, Additional monitoring, 4, Authorised (updated)
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 (updated)
06/12/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 2019
06/12/2019 Summary of opinion: Eravac, Rabbit haemorrhagic disease vaccine (inactivated), 05/12/2019, Positive
06/12/2019 Summary of opinion: Onsior, robenacoxib, 05/12/2019, Positive
06/12/2019 Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 38, Authorised (updated)
06/12/2019 Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 13, Authorised (updated)
06/12/2019 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
06/12/2019 Nitrosamine impurities overview (updated)
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 Other: Article 57 product data (updated)
06/12/2019 Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, 04/02/1998, 38, Authorised (updated)
06/12/2019 Other: Orientation guide for industry - EMA building
05/12/2019 Agenda: Agenda - CAT agenda of the 4-6 December 2019 meeting
05/12/2019 Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features , European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019 (updated)
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 Frequently asked questions about parallel distribution (updated)
05/12/2019 Procurement (updated)
05/12/2019 Procurement: Ex ante publicity of a negotiated procedure: EMA/2019/21/CO – Supply of subscriptions to general and international press in all formats
05/12/2019 Referrals document: Fluorouracil and fluorouracil related substances Article 31 referral - Timetable for the procedure (updated)
05/12/2019 Scientific publications (updated)
05/12/2019 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 17, Authorised (updated)
05/12/2019 Regulatory and procedural guideline: Recommended submission dates for centralised and maximum-residue-limit procedures (updated)
05/12/2019 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 23, Authorised (updated)
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 (updated)
05/12/2019 Authorisation of medicines (updated)
05/12/2019 What we do (updated)
04/12/2019 Human medicines European public assessment report (EPAR): Teysuno, tegafur, gimeracil, oteracil, Stomach Neoplasms, 14/03/2011, 16, Authorised (updated)
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 (updated)
04/12/2019 Herbal medicinal product: Hamamelidis cortex, Hamamelidis cortex, F: Assessment finalised (updated)
04/12/2019 Human medicines European public assessment report (EPAR): Stayveer, bosentan monohydrate, Hypertension, Pulmonary, Scleroderma, Systemic, 24/06/2013, 11, Authorised (updated)
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 (updated)
04/12/2019 Orphan designation: Ivosidenib for the: Treatment of acute myeloid leukaemia, 12/12/2016, Positive (updated)
04/12/2019 Human medicines European public assessment report (EPAR): Gardasil 9, human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed), Condylomata Acuminata, Papillomavirus Infections, Immunization, Uterine Cervical Dysplasia, 09/06/2015, Additional monitoring, 11, Authorised (updated)
04/12/2019 Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Neutropenia, 22/11/2018, Additional monitoring, Biosimilar, 1, Authorised (updated)
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 (updated)
04/12/2019 Herbal medicinal product: Frangulae cortex, Frangulae cortex, F: Assessment finalised (updated)
04/12/2019 Other: European authorities working to avoid shortages of medicines due to Brexit – Questions and answers (updated)
04/12/2019 Herbal – European Union herbal monograph: Final community herbal monograph on Hamamelis virginiana L., cortex (updated)
03/12/2019 Human medicines European public assessment report (EPAR): Olumiant, baricitinib, Arthritis, Rheumatoid, 13/02/2017, Additional monitoring, 6, Authorised (updated)
03/12/2019 Human medicines European public assessment report (EPAR): Tracleer, bosentan monohydrate, Scleroderma, Systemic, Hypertension, Pulmonary, 14/05/2002, 37, Authorised (updated)
03/12/2019 Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Mucopolysaccharidosis VII, 23/08/2018, Orphan, Additional monitoring, Exceptional circumstances, 3, Authorised (updated)
03/12/2019 Other: PRAC meetings in 2019, 2020, 2021 (updated)
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 (updated)
03/12/2019 Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 28, Authorised (updated)
03/12/2019 Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, 14/02/1996, 31, Authorised (updated)
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 (updated)
03/12/2019 Agenda: Agenda - COMP agenda of the 03-05 December 2019 meeting
03/12/2019 Third international awareness session on science and regulation for animal health and welfare, public health and the environment , European Medicines Agency, Amsterdam, the Netherlands, from 02/04/2020 to 03/04/2020
03/12/2019 Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, 13/08/1999, 40, Authorised (updated)
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 Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 9, Authorised (updated)
03/12/2019 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 10, Authorised (updated)
03/12/2019 Orphan designation: Vatiquinone for the: Treatment of RARS2 syndrome, 17/01/2018, Positive (updated)
03/12/2019 Orphan designation: (R)-troloxamide quinone for the: Treatment of amyotrophic lateral sclerosis, 12/10/2017, Positive (updated)
03/12/2019 Orphan designation: Alpha-tocotrienol quinone for the: Treatment of Leigh syndrome, 09/12/2011, Positive (updated)
03/12/2019 EPAR - All authorised presentations: Synagis : EPAR - All Authorised presentations (updated)
02/12/2019 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 39, Authorised (updated)
02/12/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
02/12/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
02/12/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
02/12/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
02/12/2019 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, Additional monitoring, 7, Authorised (updated)
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 Template or form: Template letter of intent for request of scientific advice or protocol assistance (updated)
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 (updated)
02/12/2019 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 13, Authorised (updated)
02/12/2019 Orphan designation: S-acetyl-(S)-4'-phosphopantetheine, calcium salt for the: Treatment of pantothenate-kinase-associated neurodegeneration, 28/04/2016, Positive (updated)
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 (updated)