Human medicines European public assessment report (EPAR): Ezmekly, mirdametinib, Date of authorisation: 17/07/2025, Revision: 3, Status: Authorised
Human medicines European public assessment report (EPAR): Exdensur, depemokimab, Date of authorisation: 12/02/2026, Revision: 2, Status: Authorised
Human medicines European public assessment report (EPAR): Osenvelt, denosumab, Date of authorisation: 14/02/2025, Revision: 5, Status: Authorised
PSUSA/00002420/202510
Reliance for post-authorisation changes pilots
Meeting report: Regulators-only workshop on reliance for post-approval changes (PACs) 18–19 May 2026
Reliance for postauthorisation changes (PACs): Mid-pilot review
Industry webinar on new electronic application form (eAF) version, Online, from 22 July 2026, 14:00 (CEST) to 22 July 2026, 16:00 (CEST)
Human medicines European public assessment report (EPAR): Voxzogo, vosoritide, Date of authorisation: 26/08/2021, Revision: 9, Status: Authorised
Referral: Tavneos, avacopan Article 20 procedures European Commission final decision, 25/06/2026, 04/08/2026, 13/08/2026