Product-specific bioequivalence guidance

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (27 March 2026 - 23 April 2026)

Human medicines European public assessment report (EPAR): Cimzia, certolizumab pegol, Date of authorisation: 01/10/2009, Revision: 41, Status: Authorised

Human medicines European public assessment report (EPAR): Tafinlar, dabrafenib, Date of authorisation: 26/08/2013, Revision: 40, Status: Authorised

Agenda of the CVMP meeting 19-21 May 2026

Presentation - CTIS Bitesize Talk: End of transition period and notifications including serious breaches

Human medicines European public assessment report (EPAR): Spexotras, trametinib, Date of authorisation: 05/01/2024, Revision: 10, Status: Authorised

Human medicines European public assessment report (EPAR): Procysbi, mercaptamine, Date of authorisation: 05/09/2013, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid, Date of authorisation: 03/08/2012, Revision: 15, Status: Withdrawn

Application form for the involvement of healthcare professionals’ organisations in the activities of the European Medicines Agency