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viral vector serotype 9 containing the human mini-dystrophin gene Treatment of Duchenne muscular dystrophy, 29/08/2016 Withdrawn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Z mutation of the human SERPINA1 mRNA transcript, sodium salt Treatment of alpha-1 antitrypsin deficiency, 22/08/2025 Withdrawn

Ebola

Human medicines European public assessment report (EPAR): Ixchiq, Chikungunya vaccine (live), Date of authorisation: 28/06/2024, Revision: 4, Status: Authorised

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)

Human medicines European public assessment report (EPAR): Paxlovid, nirmatrelvir,ritonavir, Date of authorisation: 28/01/2022, Revision: 30, Status: Authorised

Questions and answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies