Human medicines European public assessment report (EPAR): Evrysdi, risdiplam, Date of authorisation: 26/03/2021, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Vabysmo, faricimab, Date of authorisation: 15/09/2022, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Pomalidomide Krka, pomalidomide, Date of authorisation: 24/07/2024, Revision: 2, Status: Authorised

EMA Information Day on submission predictability of initial marketing authorisation December 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 December 2025, 13:30 (CET) to 3 December 2025, 17:30 (CET)

Human medicines European public assessment report (EPAR): Plavix, clopidogrel, Date of authorisation: 15/07/1998, Revision: 53, Status: Authorised

PSUSA/00000699/202411

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 13, Status: Authorised

PSUSA/00009247/202411

PSUSA/00001021/202411

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants