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): Mysildecard, sildenafil, Date of authorisation: 15/09/2016, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 40, Status: Authorised

Human medicines European public assessment report (EPAR): Tevimbra, tislelizumab, Date of authorisation: 15/09/2023, Revision: 15, Status: Authorised

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