SPOR and XEVMPD status update webinar - Q4 2026, Online, European Medicines Agency, Amsterdam, the Netherlands, from 7 October 2026, 10:00 (CEST) to 7 October 2026, 12:30 (CEST)

Agenda of the COMP meeting 2-3 December 2025

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): 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

Opinion on medicine for use outside EU: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda, Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated,Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated,Dengue virus, serotype 2, live, attenuated, Dengue, 13/10/2022 Positive opinion