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

Third workshop between notified bodies and expert panels , Online, from 4 December 2025, 17:30 (CET) to 4 December 2025, 18:30 (CET)

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Date of authorisation: 14/01/2019, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Velmetia, sitagliptin,metformin, Date of authorisation: 16/07/2008, Revision: 40, Status: Authorised