PSUSA/00003162/202501

Human medicines European public assessment report (EPAR): Sephience, sepiapterin, Date of authorisation: 19/06/2025, Revision: 1, Status: Authorised

Opinion on medicine for use outside EU: Lenacapavir Gilead, lenacapavir sodium, HIV Infections,HIV-1, 24/07/2025 Positive opinion

Human medicines European public assessment report (EPAR): Sunosi, solriamfetol, Date of authorisation: 16/01/2020, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Zemcelpro, allogeneic umbilical cord-derived CD34- cells, non-expanded,dorocubicel, Date of authorisation: 25/08/2025, Status: Authorised

Human medicines European public assessment report (EPAR): Ozawade, pitolisant, Date of authorisation: 01/09/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR): Amsparity, adalimumab, Date of authorisation: 13/02/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Nintedanib Viatris, nintedanib, Date of authorisation: 22/08/2025, Status: Authorised

Medicine shortage communication (MSC): Victoza 6 mg/mL solution for injection in pre-filled pen (liraglutide)