Minutes of the PRAC meeting 13-16 January 2025

Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders, Online, European Medicines Agency, Amsterdam, the Netherlands, from 11 February 2025, 15:00 (CET) to 11 February 2025, 16:00 (CET)

European Medicines Agency's data protection notice on the use of SNDS data for the performance of DARWIN EU® studies on incidence and prevalence of pathologies and use of drugs in the French population

Release notes - production release version 1.7.2514 - 12 March 2025 - Veterinary Medical Products Regulation: Union Product Database

Human medicines European public assessment report (EPAR): Paxneury, guanfacine, Date of authorisation: 26/02/2025, Status: Authorised

Human medicines European public assessment report (EPAR): Andembry, garadacimab, Date of authorisation: 10/02/2025, Status: Authorised

List of medicines currently in PRIME scheme

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting 24-27 February 2025

Orphan designation: Tafasitamab Treatment of follicular lymphoma, 26/02/2025 Positive

Orphan designation: Rimeporide Treatment of Duchenne muscular dystrophy, 26/02/2025 Positive