Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 1st October 2025
Agenda of the CVMP meeting 7-9 October 2025
Finasteride / dutasteride
PSUSA/00002413/202502
PSUSA/00003129/202501
Human medicines European public assessment report (EPAR): Minjuvi, tafasitamab, Date of authorisation: 26/08/2021, Revision: 7, Status: Authorised
Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Date of authorisation: 18/12/2020, Revision: 11, Status: Authorised
Human medicines European public assessment report (EPAR): Aplidin, plitidepsin, Status: Application withdrawn
Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), pomalidomide, Date of authorisation: 05/08/2013, Revision: 26, Status: Authorised
Q&A clinic on web-based electronic application form (eAF) functionalities for CAPs and non-CAPs, Online, European Medicines Agency, Amsterdam, the Netherlands, from 30 September 2025, 15:00 (CEST) to 30 September 2025, 16:00 (CEST)