Human medicines European public assessment report (EPAR): Dabigatran Etexilate Accord, dabigatran etexilate, Date of authorisation: 26/05/2023, Revision: 3, Status: Authorised

Orphan designation: tacrolimus monohydrate Treatment of vernal keratoconjunctivitis, 25/03/2026 Positive

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Date of authorisation: 14/01/2019, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Date of authorisation: 03/04/2020, Revision: 17, Status: Authorised

Orphan designation: atigotatug,nivolumab Treatment of pulmonary neuroendocrine carcinoma, 25/03/2026 Positive

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): 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)