Orphan designation: irpagratinib tosilate monohydrate Treatment of hepatocellular carcinoma, 25/03/2026 Positive

Orphan designation: telisotuzumab adizutecan Treatment of pancreatic cancer, 25/03/2026 Positive

Orphan designation: hydroxocobalamin acetate Treatment of homocystinuria and/or methylmalonic acidaemia due to genetic defects of intracellular cobalamin processing, 25/03/2026 Positive

Human medicines European public assessment report (EPAR): Pyrukynd, mitapivat, Date of authorisation: 09/11/2022, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Verquvo, vericiguat, Date of authorisation: 16/07/2021, Revision: 2, Status: Authorised

Clinical Data Publication (CDP) - Questions and Answers (Q&As) on the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (Policy 0070) work-share initiative with Health Canada (HC)

Human medicines European public assessment report (EPAR): Veoza, fezolinetant, Date of authorisation: 07/12/2023, Revision: 6, Status: Authorised

Agenda - PDCO agenda of the 21-24 April 2026 meeting

Human medicines European public assessment report (EPAR): Arsenic trioxide medac, arsenic trioxide, Date of authorisation: 17/09/2020, Revision: 3, Status: Authorised

Herbal medicinal product: Centaurii herba, Centaurium erythraea Rafn. s.l., C: ongoing call for scientific data