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): Arexvy, Respiratory Syncytial Virus (RSV) vaccine (recombinant, adjuvanted), Date of authorisation: 06/06/2023, Revision: 11, 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report (EPAR): Zoledronic acid medac, zoledronic acid, Date of authorisation: 03/08/2012, Revision: 15, Status: Withdrawn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

Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Date of authorisation: 09/11/2016, Revision: 25, Status: Authorised

Executive Steering Group on Shortages of Medical Devices

Orphan designation: adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene Treatment of Duchenne muscular dystrophy, 29/08/2016 Withdrawn

Orphan designation: RNA editing antisense oligonucleotide against the Z mutation of the human SERPINA1 mRNA transcript, sodium salt Treatment of alpha-1 antitrypsin deficiency, 22/08/2025 Withdrawn

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (27 February 2026 - 26 March 2026)

Start of procedure: Type II Variation - Extension of indication under evaluation by the CHMP (30 January 2026 - 26 February 2026)