HMPC: overview of assessment work - priority list

Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Date of authorisation: 19/07/2006, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR): Winrevair, Sotatercept, Date of authorisation: 22/08/2024, Revision: 1, Status: Authorised

History of EMA

Human medicines European public assessment report (EPAR): Rolufta Ellipta (previously Rolufta), umeclidinium, Date of authorisation: 20/03/2017, Revision: 14, Status: Authorised

Template for response to list of questions/list of outstanding issues: Quality / Non-clinical / Clinical

Day 80 assessment report - Non-clinical template with guidance Rev. 03.25 - Revamp

Orphan designation: Givinostat Treatment of Duchenne muscular dystrophy, 04/07/2012 Positive

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 March 2025

Summary of opinion: Xydalba, 27/03/2025 Positive