Annual activity report 2024

Human medicines European public assessment report (EPAR): Avamys, fluticasone furoate, Date of authorisation: 11/01/2008, Revision: 25, Status: Authorised

Withdrawn application: Lutathera, 09/05/2025

Human medicines European public assessment report (EPAR): Tresiba, insulin degludec, Date of authorisation: 20/01/2013, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Zoonotic Influenza Vaccine Seqirus, zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted), Date of authorisation: 09/10/2023, Revision: 3, Status: Authorised

Second EMA and European Society of Cardiology (ESC) bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, from 22 May 2025, 15:00 (CEST) to 22 May 2025, 17:00 (CEST)

Dossier administrative validation checklist for initial marketing authorisation applications by applicants

List of medicines currently in PRIME scheme

Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.16

Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms