Guidelines Consistency Group

Applications for new human medicines under evaluation: November 2025

Human medicines European public assessment report (EPAR): Erivedge, vismodegib, Date of authorisation: 12/07/2013, Date of refusal: 26/04/2013, Revision: 16, Status: Authorised

Minutes - PDCO minutes of the 9-12 September 2025 meeting

Human medicines European public assessment report (EPAR): Rekambys, rilpivirine, Date of authorisation: 17/12/2020, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Finlee, dabrafenib, Date of authorisation: 15/11/2023, Revision: 7, Status: Authorised

Timetable: Post-authorisation measures (PAMs) assessed by PRAC - ATMP

Minutes of the PRAC meeting 2-5 June 2025

Committee for Advanced Therapies (CAT): 5-7 November 2025, European Medicines Agency, Amsterdam, the Netherlands, from 5 November 2025 to 7 November 2025

Minutes of the PRAC meeting 7-10 July 2025