Tresiba

Minutes of the COMP meeting 2-3 December 2025

PhV non-compliance notification contact points at National Competent Authority (NCA) level

Human medicines European public assessment report (EPAR): Zypadhera, olanzapine, Date of authorisation: 19/11/2008, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR): Azopt, brinzolamide, Date of authorisation: 09/03/2000, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Xadago, safinamide, Date of authorisation: 23/02/2015, Revision: 16, Status: Authorised

Third European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 9 February 2026, 13:00 (CET) to 9 February 2026, 15:00 (CET)

PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC meeting

New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 January 2026 PRAC

Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products - Annex 15 - Qualification and validation