Medicines for human use under evaluation

Orphan medical devices regular process: Guide for applicants

Orphan medical devices regular process: 2026 timetable

Clinical advice request: Template for applicants

Orphan status request: Template for applicants

Human medicines European public assessment report (EPAR): Eliquis, apixaban, Date of authorisation: 18/05/2011, Revision: 40, Status: Authorised

Human medicines European public assessment report (EPAR): Winrevair, sotatercept, Date of authorisation: 22/08/2024, Revision: 3, Status: Authorised

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

Human medicines European public assessment report (EPAR): LysaKare, arginine,lysine, Date of authorisation: 25/07/2019, Revision: 10, Status: Authorised

Scientific Advisory Group on Immune and Inflammatory Diseases