Clinical trials in human medicines

Human medicines European public assessment report (EPAR): Arava, leflunomide, Date of authorisation: 02/09/1999, Revision: 45, Status: Authorised

Human medicines European public assessment report (EPAR): Synflorix, pneumococcal polysaccharide conjugate vaccine (adsorbed), Date of authorisation: 29/03/2009, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR): Tecartus, brexucabtagene autoleucel, Date of authorisation: 14/12/2020, Revision: 18, Status: Authorised

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