Human medicines European public assessment report (EPAR): Amtagvi, lifileucel, Status: Application withdrawn

Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation - Scientific guideline

Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation

Human medicines European public assessment report (EPAR): Tofidence, tocilizumab, Date of authorisation: 20/06/2024, Revision: 3, Status: Authorised

PSUSA/00002737/202501

Overview of (invented) names reviewed in September 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 16 October 2025

Orphan designation: recombinant human N-acetylgalactosamine-6-sulfatase (elosulfase alfa) Treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome), 24/07/2009 Withdrawn

Human medicines European public assessment report (EPAR): Vimizim, elosulfase alfa, Date of authorisation: 27/04/2014, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Camzyos, mavacamten, Date of authorisation: 26/06/2023, Revision: 6, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Volibris, ambrisentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: P/0384/2024