Agenda of the COMP meeting 2-3 December 2025

20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 November 2025, 13:30 (CET) to 13 November 2025, 17:40 (CET)

PSUSA/00010883/202504

PSUSA/00003097/202501

Human medicines European public assessment report (EPAR): Xofluza, baloxavir marboxil, Date of authorisation: 07/01/2021, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Rasagiline Viatris (previously Rasagiline Mylan), rasagiline, Date of authorisation: 04/04/2016, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Adynovi, rurioctocog alfa pegol, Date of authorisation: 08/01/2018, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Benepali, etanercept, Date of authorisation: 13/01/2016, Revision: 28, Status: Authorised

Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Date of authorisation: 21/03/2007, Revision: 42, Status: Authorised

Human medicines European public assessment report (EPAR): Cerezyme, imiglucerase, Date of authorisation: 17/11/1997, Revision: 34, Status: Authorised