Human medicines European public assessment report (EPAR): Imfinzi, durvalumab, Date of authorisation: 21/09/2018, Revision: 28, Status: Authorised

Highlights from the third expert panels and notified bodies workshop

Human medicines European public assessment report (EPAR): Usrenty, ustekinumab, Date of authorisation: 17/09/2025, Revision: 2, Status: Authorised

EMA risk management information day, European Medicines Agency, Amsterdam, the Netherlands, from 8 September 2026, 09:00 (CEST) to 8 September 2026, 17:00 (CEST)

Highlights from the second expert panels and notified bodies workshop

Annex to agenda of the CHMP meeting 18-21 May 2026

Agenda of the CHMP meeting 18-21 May 2026

Human medicines European public assessment report (EPAR): Sapropterin Dipharma, sapropterin, Date of authorisation: 16/02/2022, Revision: 8, Status: Authorised

Orphan designation: orvepitant maleate Treatment of idiopathic pulmonary fibrosis, 21/11/2025 Withdrawn

Orphan designation: 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide Treatment of congenital hyperinsulinism, 09/12/2020 Withdrawn