Kick-off meeting of the HMA-EMA group focused on AI with industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 November 2025, 09:00 (CET) to 7 November 2025, 10:30 (CET)

Veterinary medicines European public assessment report (EPAR): Hemosyvet, etamsylate, Status: Authorised

PSUSA/00002203/202504

List of centrally authorised products with safety-related changes to the product information

PSUSA/00010377/202504

Human medicines European public assessment report (EPAR): Atropine sulfate FGK, atropine, Date of refusal: 21/11/2025, Status: Refused

Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Date of authorisation: 26/03/2021, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Talvey, talquetamab, Date of authorisation: 21/08/2023, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Memantine Mylan, memantine, Date of authorisation: 21/04/2013, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR): Fingolimod Mylan, fingolimod, Date of authorisation: 18/08/2021, Revision: 9, Status: Authorised