Breakthrough status request: Template for applicants for breakthrough medical devices pilot

Fifth European Medicines Agency (EMA) and Affordable Medicines Europe bilateral meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, 11 September 2026

Organisation chart: Veterinary Medicines

Human medicines European public assessment report (EPAR): Multaq, dronedarone, Date of authorisation: 25/11/2009, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Aspaveli, pegcetacoplan, Date of authorisation: 13/12/2021, Revision: 14, Status: Authorised

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (26 June 2026 - 23 July 2026)

Start of procedure: Extension of marketing authorisation (26 June 2026 - 23 July 2026)

New leadership team appointments

Dates of 2027 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel HTACG/EMA Joint Scientific Consultation requests

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2026