Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Date of authorisation: 19/01/2007, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Date of authorisation: 17/07/2015, Revision: 70, Status: Authorised

Human medicines European public assessment report (EPAR): Enflonsia, clesrovimab, Date of authorisation: 15/04/2026, 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): 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)