PDCO minutes of the 9-12 December 2025 meeting

Human medicines European public assessment report (EPAR): Yesintek, ustekinumab, Date of authorisation: 14/02/2025, Revision: 3, Status: Authorised

Good pharmacovigilance practices (GVP)

Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Date of authorisation: 26/07/2018, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Ibuprofen Gen.Orph, ibuprofen, Date of authorisation: 16/02/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Enspryng, satralizumab, Date of authorisation: 24/06/2021, Revision: 8, Status: Authorised

PSUSA/00009225/202506

PSUSA/00000080/202506

Herbal medicinal product: Ribis nigri folium, Ribes nigrum L., P: Draft published

Draft European Union herbal monograph on Ribes nigrum L., folium - Revision 2