Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) service, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 November 2025, 14:00 (CET) to 18 November 2025, 15:00 (CET)

CAT quarterly highlights and approved ATMPs - December 2025

Opinion on medicine for use outside EU: Aluvia, lopinavir,ritonavir, HIV Infections, 21/09/2006 Positive opinion

Outcomes of imposed non-interventional post-authorisation safety studies

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 65, Status: Authorised

Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Date of authorisation: 19/06/2015, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Izamby, denosumab, Date of authorisation: 26/06/2025, Revision: 2, Status: Authorised

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

Human medicines European public assessment report (EPAR): Upstaza, eladocagene exuparvovec, Date of authorisation: 18/07/2022, Revision: 9, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Ilumetri, tildrakizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Musculoskeletal and connective tissue disorders, PIP number: P/0388/2024