Breakthrough status request: Template for applicants for breakthrough medical devices pilot

Advice request: Template for applicants for breakthrough medical devices pilot

CVMP Interested Parties’ meeting 2026, European Medicines Agency, Amsterdam, the Netherlands, from 20 May 2026, 17:00 (CEST) to 20 May 2026, 19:00 (CEST)

Withdrawn application: Pluvicto, 23/04/2026

Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1

Use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union - Scientific guideline

Human medicines European public assessment report (EPAR): Vysribli (previously Denosumab Intas), Vysribli, Date of authorisation: 17/11/2025, Revision: 1, Status: Authorised

New medicine to reduce triglycerides in adults with familial chylomicronaemia syndrome

Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, risankizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Dermatology, PIP number: P/0497/2022

Human medicines European public assessment report (EPAR): Terrosa, teriparatide, Date of authorisation: 04/01/2017, Revision: 8, Status: Authorised