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): Pyzchiva, ustekinumab, Date of authorisation: 19/04/2024, Revision: 11, Status: Authorised

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

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

Good pharmacovigilance practices (GVP)

Human medicines European public assessment report (EPAR): Afinitor, everolimus, Date of authorisation: 02/08/2009, Revision: 32, Status: Authorised

Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

Human medicines European public assessment report (EPAR): Sarclisa, isatuximab, Date of authorisation: 30/05/2020, Revision: 13, Status: Authorised