Human medicines European public assessment report (EPAR): Sephience, sepiapterin, Date of authorisation: 19/06/2025, Revision: 3, Status: Authorised
Summary of opinion: BTVPUR, 21/05/2026 Positive
Human medicines European public assessment report (EPAR): Osvyrti, denosumab, Date of authorisation: 26/05/2025, Revision: 2, Status: Authorised
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2026
Summary of opinion: Braftovi, 21/05/2026 Positive
Summary of opinion: Iclusig, 21/05/2026 Positive
Summary of opinion: Tepkinly, 21/05/2026 Positive
Orphan designation: bevacizumab Treatment of hereditary haemorrhagic telangiectasia, 16/12/2014 Positive
Orphan designation: alpelisib Treatment of PIK3CA related overgrowth spectrum, 26/03/2021 Positive
Orphan designation: Copper (64Cu) oxodotreotide Diagnosis of neuroendocrine neoplasms, 09/12/2022 Positive