Human medicines European public assessment report (EPAR): Pirfenidone Viatris, pirfenidone, Date of authorisation: 10/01/2023, Revision: 4, Status: Authorised

Summary of opinion: Hetlioz, 11/12/2025 Negative

Human medicines European public assessment report (EPAR): Macitentan Accord, macitentan, Date of authorisation: 24/09/2025, Status: Authorised

Technology Capability Investment Plan to 2028 - Becoming a digital hub for the European medicines regulator network

Information management

PSUSA/00002502/202503

Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Date of authorisation: 02/05/1996, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): RotaTeq, rotavirus vaccine, live, Date of authorisation: 26/06/2006, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR): Orgalutran, ganirelix, Date of authorisation: 16/05/2000, Revision: 26, Status: Authorised