Standard operating procedure for procedure to be followed when the incident management plan for medicines for veterinary use is triggered
Human medicines European public assessment report (EPAR): Degevma, denosumab, Date of authorisation: 17/11/2025, Status: Authorised
New product information wording: extracts from PRAC recommendations on signals adopted at the 27-30 October 2025 PRAC
Fourth European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 8 December 2025, 13:00 (CET) to 8 December 2025, 15:00 (CET)
Applications for new human medicines under evaluation: January 2026
Questions and answers on signal management
New variations guidelines: webinar for marketing authorisation holders (human), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 13 January 2026, 13:00 (CET) to 13 January 2026, 15:00 (CET)
Agenda of the COMP meeting 20-22 January 2026
Human medicines European public assessment report (EPAR): Abiraterone Mylan, abiraterone acetate, Date of authorisation: 20/08/2021, Revision: 7, Status: Authorised
Human medicines European public assessment report (EPAR): Xenpozyme, olipudase alfa, Date of authorisation: 24/06/2022, Revision: 8, Status: Authorised