List of centrally authorised products with safety-related changes to the product information

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004

Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2

Minutes of the CAT meeting 22-24 January 2025

Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Date of authorisation: 23/04/2007, Revision: 29, Status: Authorised

Infographic - Orphan Medicines in the EU

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

Clinical Trial Information System (CTIS) evaluation timelines

Human medicines European public assessment report (EPAR): Biktarvy, bictegravir,emtricitabine,tenofovir alafenamide, Date of authorisation: 21/06/2018, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Date of authorisation: 08/01/2018, Revision: 16, Status: Authorised