PRAC recommendations on signals adopted at the 7-10 July 2025 PRAC meeting

Human medicines European public assessment report (EPAR): Elahere, mirvetuximab soravtansine, Date of authorisation: 14/11/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), mercaptopurine, Date of authorisation: 09/03/2012, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Rimmyrah, ranibizumab, Date of authorisation: 05/01/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Opzelura, ruxolitinib, Date of authorisation: 19/04/2023, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Abrysvo, respiratory syncytial virus vaccine (bivalent, recombinant), Date of authorisation: 23/08/2023, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Ezmekly, mirdametinib, Date of authorisation: 17/07/2025, Status: Authorised

List of signals discussed at PRAC since September 2012

Human medicines European public assessment report (EPAR): Usymro, ustekinumab, Date of authorisation: 14/08/2025, Status: Authorised

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 13, Status: Authorised