Policy 82: Union Product Database (UPD) Access Policy - Veterinary Medicinal Products
List of medicines currently in PRIME scheme
Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 July 2024
Human medicines European public assessment report (EPAR): Vazkepa, icosapent ethyl, Date of authorisation: 26/03/2021, Revision: 7, Status: Authorised
Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines, Online, European Medicines Agency, Amsterdam, the Netherlands, from 19 June 2024, 13:00 (CEST) to 19 June 2024, 18:00 (CEST)
Human medicines European public assessment report (EPAR): Durveqtix, fidanacogene elaparvovec, Date of authorisation: 24/07/2024, Status: Authorised
Orphan designation: Recombinant human ADAMTS-13 Treatment of thrombotic thrombocytopenic purpura, 03/12/2008 Positive
Real-world evidence
Infosheet: EMA review of real-world data studies
Real-world evidence framework to support EU regulatory decision-making: 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024