Minutes of the PRAC meeting 5-8 May 2025

Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Date of authorisation: 21/02/2005, Revision: 22, Status: Authorised

Strengthening supply chain of anti-D immunoglobulins

Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products to address anti-D immunoglobulin supply chain vulnerabilities

Human medicines European public assessment report (EPAR): Neoatricon, dopamine hydrochloride, Date of authorisation: 27/05/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Tivdak, tisotumab vedotin, Date of authorisation: 28/03/2025, Revision: 2, Status: Authorised

Agenda of the HMPC meeting 7-9 July 2025

First EMA-ACRO bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 2 September 2025

Human medicines European public assessment report (EPAR): Lyvdelzi (previously Seladelpar Gilead), seladelpar lysine dihydrate, Revision: 3, Status: Authorised

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.16