EMA/PE/0000257243

EMA/PE/0000231113

Human medicines European public assessment report (EPAR): Inluriyo, imlunestrant, Date of authorisation: 09/01/2026, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Date of authorisation: 12/12/2018, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Emblaveo, aztreonam,avibactam, Date of authorisation: 22/04/2024, Revision: 3, Status: Authorised

Agenda of the CHMP meeting 23-26 February 2026

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