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

Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 1 April 2025

New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC

Policy 85: Identity and Access Management to EMA IT Systems

Quarterly System Demo - Q1 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 26 March 2025, 09:00 (CET) to 26 March 2025, 11:30 (CET)

Human medicines European public assessment report (EPAR): Laventair Ellipta (previously Laventair), umeclidinium bromide,vilanterol, Date of authorisation: 08/05/2014, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Respreeza, alpha1-proteinase inhibitor (human), Date of authorisation: 20/08/2015, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Zeposia, ozanimod, Date of authorisation: 20/05/2020, Revision: 9, Status: Authorised

Product Management Service (PMS) webinar : Unlocking Integration – MAH & Software Developers to explore PMS API Machine-to-Machine Connection, Online, European Medicines Agency, Amsterdam, the Netherlands, from 14 March 2025, 10:00 (CET) to 14 March 2025, 12:00 (CET)

Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen,human thrombin, Date of authorisation: 10/11/2017, Revision: 10, Status: Authorised