PSUSA/00010217/202509

Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva, tenofovir disoproxil, Date of authorisation: 15/09/2016, Revision: 16, Status: Authorised

Withdrawn application: Pluvicto, 23/04/2026

Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Date of authorisation: 30/05/2017, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Livtencity, maribavir, Date of authorisation: 09/11/2022, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Qtern, saxagliptin,dapagliflozin, Date of authorisation: 15/07/2016, Revision: 16, Status: Authorised

Questions and answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 9 June 2026

Process for the electronic submission of medicinal product information - Chapter 3

European Medicines Agency’s data protection notice for the EMA Account Management system

EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines