Human medicines European public assessment report (EPAR): Seladelpar Gilead, Seladelpar lysine dihydrate, Revision: 1, Status: Authorised
Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Blood and lymphatic system disorders, PIP number: P/0040/2024
PhV non-compliance notification contact points at National Competent Authority (NCA) level
EMA establishes regular procedure for scientific advice on certain high-risk medical devices
Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations, Online, European Medicines Agency, Amsterdam, the Netherlands, from 13 March 2025, 11:30 (CET) to 13 March 2025, 12:00 (CET)
QRD Form 2 and checklist for the submission of day +25 files - veterinary
Minutes of the CAT meeting 4-6 December 2024
Annex to 24-27 March 2025 CHMP Agenda
Agenda of the CHMP meeting 24-27 March 2025
Pilot on advice from expert panels to manufacturers of high-risk medical devices: Interim report on the experience with the pilot from February 2023 to December 2024