Human medicines European public assessment report (EPAR): Altuvoct, efanesoctocog alfa, Date of authorisation: 17/06/2024, Revision: 2, Status: Authorised

PSUSA/00002039/202503

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

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine, Date of authorisation: 21/12/2020, Revision: 57, Status: Authorised

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

Information management

Human medicines European public assessment report (EPAR): Afqlir, aflibercept, Date of authorisation: 13/11/2024, Revision: 5, Status: Authorised

PSUSA/00002502/202503