Agenda - Sixth Veterinary Data Stakeholder Forum

Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

PSUSA/00001026/202512

Human medicines European public assessment report (EPAR): Leqvio, inclisiran, Date of authorisation: 09/12/2020, Revision: 13, Status: Authorised

Health technology assessment bodies

Human medicines European public assessment report (EPAR): Silapo, epoetin zeta, Date of authorisation: 18/12/2007, Revision: 19, Status: Authorised

Highlights - First European Medicines Agency (EMA) - International Society for Cell and Gene Therapy (ISCT) bilateral meeting

Minutes of PRAC meeting on 31 August - 3 September 2026

Human medicines European public assessment report (EPAR): Trixeo Aerosphere, formoterol,glycopyrronium bromide,budesonide, Date of authorisation: 09/12/2020, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR): Lamzede, velmanase alfa, Date of authorisation: 23/03/2018, Revision: 8, Status: Authorised