Human medicines European public assessment report (EPAR): Yargesa, miglustat, Date of authorisation: 22/03/2017, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Simulect, basiliximab, Date of authorisation: 09/10/1998, Revision: 30, Status: Authorised

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

PSUSA/00002640/202503

Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Date of authorisation: 06/05/2011, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Ruconest, conestat alfa, Date of authorisation: 28/10/2010, Revision: 15, Status: Authorised

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