Agenda - HMA/EMA Annual Data Forum 2025

Human medicines European public assessment report (EPAR): Dectova, zanamivir, Date of authorisation: 26/04/2019, Revision: 8, Status: Authorised

Annex to agenda of the CHMP meeting 10-13 November 2025

Agenda of the CHMP meeting 10-13 November 2025

Human medicines European public assessment report (EPAR): Rezdiffra, resmetirom, Date of authorisation: 18/08/2025, Status: Authorised

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025

Human medicines European public assessment report (EPAR): HBVaxPro, hepatitis B vaccine (recombinant DNA), Date of authorisation: 27/04/2001, Revision: 35, Status: Authorised

MSSG Voluntary Solidarity Mechanism

Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)

Human medicines European public assessment report (EPAR): Baiama, aflibercept, Date of authorisation: 13/01/2025, Revision: 3, Status: Authorised