29/05/2024 | Medicine: Dynastat | Updated |
29/05/2024 | Page: National registers of authorised medicines | Updated |
29/05/2024 | Medicine: Zolsketil pegylated liposomal | Updated |
29/05/2024 | Medicine: Omlyclo | Updated |
28/05/2024 | Medicine: Zoonotic Influenza Vaccine Seqirus | Updated |
28/05/2024 | PSUSA: PSUSA/00001642/202309 - periodic safety update report single assessment | New |
28/05/2024 | Medicine: Filspari | Updated |
28/05/2024 | PIP: EMEA-002233-PIP01-17-M02 - paediatric investigation plan | Updated |
28/05/2024 | Medicine: Truvada | Updated |
28/05/2024 | Medicine: Xromi | Updated |
28/05/2024 | Medicine: Reagila | Updated |
28/05/2024 | Document: Sodium salicylate (poultry other than turkey): European Public MRL Assessment Report (EPMAR) - CVMP | New |
28/05/2024 | Medicine: Sarclisa | Updated |
28/05/2024 | Medicine: Filgrastim Hexal | Updated |
28/05/2024 | Document: Agenda - PDCO agenda of the 28-31 May 2024 meeting | New |
28/05/2024 | Event: DARWIN EU Advisory Board meeting - 11 December 2023 | Updated |
28/05/2024 | Medicine: Zarzio | Updated |
28/05/2024 | Medicine: Retsevmo | Updated |
28/05/2024 | Medicine: Betmiga | Updated |
28/05/2024 | Medicine: Nuceiva | Updated |
27/05/2024 | Medicine: Loargys | Updated |
27/05/2024 | Document: Agenda of the CHMP meeting 27-30 May 2024 | New |
27/05/2024 | Medicine: Vectormune FP ILT | Updated |
27/05/2024 | Medicine: Ronapreve | Updated |
27/05/2024 | Medicine: Rotarix | Updated |
24/05/2024 | Medicine: Sotyktu | Updated |
24/05/2024 | Medicine: Tenofovir disoproxil Zentiva | Updated |
24/05/2024 | Medicine: Vyvgart | Updated |
24/05/2024 | Medicine: Rinvoq | Updated |
24/05/2024 | Medicine: Vyxeos liposomal (previously known as Vyxeos) | Updated |
24/05/2024 | Medicine: Saphnelo | Updated |
24/05/2024 | Medicine: Nexviadyme | Updated |
24/05/2024 | Medicine: Benlysta | Updated |
24/05/2024 | Event: Committee for Herbal Medicinal Products (HMPC): 27-29 May 2024 | Updated |
24/05/2024 | Medicine: Orserdu | Updated |
24/05/2024 | Medicine: Skyrizi | Updated |
24/05/2024 | Medicine: TachoSil | Updated |
24/05/2024 | Medicine: Locametz | Updated |
24/05/2024 | Medicine: Sprycel | Updated |
24/05/2024 | Medicine: Atazanavir Viatris (previously Atazanavir Mylan) | Updated |
24/05/2024 | Post-authorisation: Bluevac BTV (previously known as Bluevac BTV8) - opinion on variation to marketing authorisation | New |
24/05/2024 | Medicine: Nobilis Multriva RT+IBm+ND+Gm+REOm | New |
24/05/2024 | Medicine: Nobilis Multriva RT+IBm+ND+EDS | New |
24/05/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024 | New |
24/05/2024 | Medicine: Darunavir Viatris (previously Darunavir Mylan) | Updated |
24/05/2024 | Page: Industry annual bilateral meetings | Updated |
24/05/2024 | Event: Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting | New |
23/05/2024 | Event: European Shortages Monitoring Platform Essentials and Industry Reporting Requirements | New |
23/05/2024 | Medicine: Binocrit | Updated |
23/05/2024 | Medicine: Epoetin Alfa Hexal | Updated |
23/05/2024 | Medicine: Abseamed | Updated |
23/05/2024 | Medicine: Spravato | Updated |
23/05/2024 | Medicine: Tizveni | Updated |
23/05/2024 | Event: Environmental Risk Assessment (ERA) Assessors Training | New |
23/05/2024 | Medicine: Strangvac | Updated |
23/05/2024 | Medicine: Lumykras | Updated |
23/05/2024 | Medicine: Arexvy | Updated |
23/05/2024 | Herbal: Rhodiolae roseae rhizoma et radix - herbal medicinal product | Updated |
23/05/2024 | Medicine: LysaKare | Updated |
23/05/2024 | Medicine: Zonisamide Mylan | Updated |
23/05/2024 | Medicine: Enerzair Breezhaler | Updated |
23/05/2024 | Medicine: Loxitab | Updated |
23/05/2024 | Medicine: Eluracat | Updated |
23/05/2024 | Medicine: Oxmax | Updated |
23/05/2024 | Medicine: Atectura Breezhaler | Updated |
23/05/2024 | Medicine: Cerezyme | Updated |
22/05/2024 | Medicine: Ibrance | Updated |
22/05/2024 | Medicine: Nubeqa | Updated |
22/05/2024 | Medicine: Imvanex | Updated |
22/05/2024 | Medicine: Flixabi | Updated |
22/05/2024 | Medicine: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) | Updated |
22/05/2024 | Medicine: Amgevita | Updated |
22/05/2024 | Medicine: Krazati | Updated |
22/05/2024 | Medicine: Tevimbra | Updated |
22/05/2024 | Medicine: Spexotras | Updated |
22/05/2024 | Medicine: Roclanda | Updated |
22/05/2024 | Medicine: Stayveer | Updated |
22/05/2024 | Medicine: Fulvestrant Mylan | Updated |
22/05/2024 | Medicine: Mekinist | Updated |
22/05/2024 | Medicine: Viagra | Updated |
21/05/2024 | PIP: EMEA-003273-PIP02-22 - paediatric investigation plan | New |
21/05/2024 | PSUSA: PSUSA/00000958/202309 - periodic safety update report single assessment | New |
21/05/2024 | PIP: EMEA-003090-PIP02-22 - paediatric investigation plan | New |
21/05/2024 | PIP: EMEA-003355-PIP01-22 - paediatric investigation plan | New |
21/05/2024 | Medicine: Tafinlar | Updated |
21/05/2024 | Medicine: Finlee | Updated |
21/05/2024 | Medicine: Tecentriq | Updated |
21/05/2024 | Medicine: Quviviq | Updated |
21/05/2024 | Medicine: Erleada | Updated |
21/05/2024 | Medicine: Tepmetko | Updated |
21/05/2024 | Event: Product Management Service (PMS) Product UI and API training (access & navigation) | Updated |
21/05/2024 | Medicine: Palonosetron Accord | Updated |
21/05/2024 | News: EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna | Updated |
21/05/2024 | Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) | Updated |
21/05/2024 | Medicine: Mysildecard | Updated |
21/05/2024 | Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes | Updated |
21/05/2024 | Medicine: Apremilast Accord | Updated |
21/05/2024 | Medicine: Cresemba | Updated |
21/05/2024 | Medicine: Temozolomide Sun | Updated |
21/05/2024 | Document: Agenda of the CVMP meeting 21-23 May 2024 | New |
21/05/2024 | Document: Agenda of the COMP meeting 21-23 May 2024 | New |
21/05/2024 | Medicine: Evenity | Updated |
21/05/2024 | Medicine: Rekambys | Updated |
17/05/2024 | PSUSA: PSUSA/00010768/202310 - periodic safety update report single assessment | New |
17/05/2024 | Medicine: Trepulmix | Updated |
17/05/2024 | Medicine: Ajovy | Updated |
17/05/2024 | Medicine: Voydeya | Updated |
17/05/2024 | Medicine: Onivyde pegylated liposomal (previously known as Onivyde) | Updated |
17/05/2024 | Page: Outcomes of imposed non-interventional post-authorisation safety studies | Updated |
17/05/2024 | Medicine: Miglustat Gen.Orph | Updated |
17/05/2024 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024 | New |
17/05/2024 | Medicine: Tracleer | Updated |
17/05/2024 | Medicine: Zepatier | Updated |
16/05/2024 | PSUSA: PSUSA/00002569/202309 - periodic safety update report single assessment | New |
16/05/2024 | PSUSA: PSUSA/00000034/202309 - periodic safety update report single assessment | New |
16/05/2024 | PSUSA: PSUSA/00010806/202310 - periodic safety update report single assessment | New |
16/05/2024 | Document: Sodium tetradecyl sulphate: List of nationally authorised medicinal products - PSUSA/00002767/202304 | New |
16/05/2024 | Medicine: Nplate | Updated |
16/05/2024 | Medicine: Kalydeco | Updated |
16/05/2024 | Medicine: Temozolomide Teva | Updated |
16/05/2024 | Document: PDCO minutes of the 19-22 March 2024 meeting | New |
16/05/2024 | Medicine: Colobreathe | Updated |
16/05/2024 | Medicine: Fingolimod Accord | Updated |
16/05/2024 | Event: Information and Q&A session on updated CAPs in web-based eAF | Updated |
16/05/2024 | Medicine: Pregabalin Sandoz | Updated |
16/05/2024 | Medicine: Pregabalin Mylan | Updated |
16/05/2024 | Medicine: Ibuprofen Gen.Orph | Updated |
15/05/2024 | Medicine: Brukinsa | Updated |
15/05/2024 | Document: Policy 78: EMA environmental policy | Updated |
15/05/2024 | Medicine: Tasigna | Updated |
15/05/2024 | Medicine: Ryzneuta | Updated |
15/05/2024 | Medicine: Imcivree | Updated |
15/05/2024 | Medicine: Neuraceq | Updated |
15/05/2024 | Medicine: Lyrica | Updated |
15/05/2024 | Medicine: Kaftrio | Updated |
15/05/2024 | Medicine: Uptravi | Updated |
14/05/2024 | Medicine: Thalidomide Lipomed | Updated |
14/05/2024 | Medicine: Mayzent | Updated |
14/05/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - July 2024 | Updated |
14/05/2024 | Medicine: Olanzapine Mylan | Updated |
14/05/2024 | Medicine: Vegzelma | Updated |
14/05/2024 | Medicine: Poteligeo | Updated |
14/05/2024 | Medicine: Aspaveli | Updated |
13/05/2024 | Medicine: GONAL-f | Updated |
13/05/2024 | Medicine: Agamree | Updated |
13/05/2024 | Medicine: Axumin | Updated |
13/05/2024 | Medicine: Bexsero | Updated |
13/05/2024 | Medicine: Ghryvelin (previously Macimorelin Aeterna Zentaris) | Updated |
13/05/2024 | Medicine: Scenesse | Updated |
13/05/2024 | Medicine: Anagrelide Viatris (previously Anagrelide Mylan) | Updated |
13/05/2024 | Medicine: Myozyme | Updated |
13/05/2024 | Medicine: Fabrazyme | Updated |
13/05/2024 | Medicine: Kauliv | Updated |
13/05/2024 | Medicine: Onglyza | Updated |
13/05/2024 | Medicine: Rasagiline Mylan | Updated |
13/05/2024 | Medicine: Plerixafor Accord | Updated |
13/05/2024 | Medicine: Atriance | Updated |
13/05/2024 | Medicine: Spinraza | Updated |
13/05/2024 | Medicine: Granupas (previously Para-aminosalicylic acid Lucane) | Updated |
13/05/2024 | Medicine: Vyndaqel | Updated |
13/05/2024 | Medicine: Dupixent | Updated |
13/05/2024 | Medicine: Telmisartan Actavis | Updated |
13/05/2024 | Medicine: Luxturna | Updated |
13/05/2024 | Medicine: Leqvio | Updated |
13/05/2024 | Medicine: Heplisav B | Updated |
13/05/2024 | Medicine: Orkambi | Updated |
13/05/2024 | Medicine: Reblozyl | Updated |
13/05/2024 | Medicine: Abrysvo | Updated |
13/05/2024 | Medicine: Keytruda | Updated |
13/05/2024 | Medicine: Tresiba | Updated |
13/05/2024 | Medicine: Isentress | Updated |
13/05/2024 | Medicine: Ryzodeg | Updated |
08/05/2024 | Document: Timetable: Post-authorisation safety study (PASS) protocols and final results | Updated |
08/05/2024 | Document: Timetable: Initial (Full) marketing authorisation application - ATMP | Updated |
07/05/2024 | Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | Updated |
07/05/2024 | Herbal: Hippocastani cortex - herbal medicinal product | Updated |
07/05/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 | Updated |
07/05/2024 | Event: Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa" | New |
07/05/2024 | Document: List of medicines currently in PRIME scheme | Updated |
07/05/2024 | Medicine: Emblaveo | Updated |
06/05/2024 | Event: EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | Updated |
06/05/2024 | PSUSA: PSUSA/00002310/202308 - periodic safety update report single assessment | New |
06/05/2024 | Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma Workshop | New |
06/05/2024 | Medicine: Adynovi | Updated |
06/05/2024 | Medicine: Advate | Updated |
06/05/2024 | Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meeting | New |
03/05/2024 | Medicine: MenQuadfi | Updated |
03/05/2024 | PIP: EMEA-003157-PIP01-21 - paediatric investigation plan | Updated |
03/05/2024 | Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
03/05/2024 | PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessment | New |
03/05/2024 | Medicine: Briumvi | Updated |
03/05/2024 | Medicine: Sivextro | Updated |
03/05/2024 | Medicine: Talzenna | Updated |
02/05/2024 | Document: Template for scientific document (part B-F) | Updated |
02/05/2024 | Herbal: Malvae sylvestris flos - herbal medicinal product | Updated |
02/05/2024 | Medicine: Pelmeg | Updated |
02/05/2024 | Medicine: Noxafil | Updated |
02/05/2024 | Medicine: Teriflunomide Accord | Updated |
02/05/2024 | Medicine: Byooviz | Updated |
02/05/2024 | Medicine: Pluvicto | Updated |
02/05/2024 | Medicine: RotaTeq | Updated |
02/05/2024 | Medicine: Volibris | Updated |
02/05/2024 | Herbal: Malvae folium - herbal medicinal product | Updated |
02/05/2024 | Medicine: Vafseo | Updated |
02/05/2024 | Medicine: Incellipan | Updated |
02/05/2024 | Medicine: Celldemic | Updated |
02/05/2024 | Medicine: Zynyz | Updated |
02/05/2024 | Document: CAT quarterly highlights and approved ATMPs - February - April 2024 | New |
02/05/2024 | Page: Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guideline | Updated |
02/05/2024 | Medicine: Mirapexin | Updated |