PSUSA/00000851/202503

Human medicines European public assessment report (EPAR): Roctavian, valoctocogene roxaparvovec, Date of authorisation: 24/08/2022, Revision: 10, Status: Authorised

EMA and FDA set common principles for AI in medicine development

Human medicines European public assessment report (EPAR): Otezla, apremilast, Date of authorisation: 15/01/2015, Revision: 25, Status: Authorised

Guiding principles of good AI practice in drug development

Human medicines European public assessment report (EPAR): Yesafili, aflibercept, Date of authorisation: 15/09/2023, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Zvogra, denosumab, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Abiraterone Accord, abiraterone, Date of authorisation: 26/04/2021, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Stoboclo, denosumab, Date of authorisation: 14/02/2025, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR): Nemluvio, nemolizumab, Date of authorisation: 12/02/2025, Revision: 4, Status: Authorised