Minutes of the CAT meeting 11-13 June 2025

Human medicines European public assessment report (EPAR): Nubeqa, darolutamide, Date of authorisation: 27/03/2020, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Vevzuo, denosumab, Date of authorisation: 25/06/2025, Revision: 1, Status: Authorised

List of centrally authorised products with safety-related changes to the product information

Human medicines European public assessment report (EPAR): Jeraygo, aprocitentan, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Spexotras, trametinib, Date of authorisation: 05/01/2024, Revision: 8, Status: Authorised

Dynastat

Human medicines European public assessment report (EPAR): Rivaroxaban Accord, rivaroxaban, Date of authorisation: 16/11/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Date of authorisation: 18/05/2020, Revision: 20, Status: Authorised

Good pharmacovigilance practices (GVP)