Questions and answers on signal management
Questions and answers on signal management
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
Human medicines European public assessment report (EPAR): Effentora, fentanyl, Date of authorisation: 04/04/2008, Revision: 33, Status: Authorised
Human medicines European public assessment report (EPAR): Brintellix, vortioxetine, Date of authorisation: 18/12/2013, Revision: 26, Status: Authorised
Veterinary medicines in 2025
HMA/EMA multi-stakeholder workshop on artificial intelligence (AI), Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 20 November 2025, 13:00 (CET) to 21 November 2025, 12:50 (CET)
Submission deadlines for orphan designations