Annex to agenda of the CHMP meeting 23-26 February 2026

Human medicines European public assessment report (EPAR): Dawnzera, donidalorsen, Date of authorisation: 19/01/2026, Status: Authorised

ICH M4Q - The Common Technical Document for the registration of pharmaceuticals for human use - Quality - Scientific guideline

Overview of comments on ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b

Committee for Medicinal Products for Veterinary Use (CVMP): 13-15 January 2026, European Medicines Agency, Amsterdam, the Netherlands, from 13 January 2026 to 15 January 2026

Minutes of the CVMP meeting 13-15 January 2026

Minutes of the CVMP meeting 2-4 December 2025

Human medicines European public assessment report (EPAR): Osqay, denosumab, Date of authorisation: 08/01/2026, Status: Authorised

Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Date of authorisation: 23/03/2018, Revision: 11, Status: Authorised

Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products