EMA confirms suspension of sickle cell disease medicine Oxbryta

Summary of opinion: Tremfya, 16/10/2025 Positive

Opinion on medicine for use outside EU: Fexinidazole Winthrop, fexinidazole, Trypanosomiasis, African, 15/11/2018 Positive opinion

EMEA-002166-PIP01-17-M08

Human medicines European public assessment report (EPAR): Arava, leflunomide, Date of authorisation: 02/09/1999, Revision: 43, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0339/2024

Opinion/decision on a Paediatric investigation plan (PIP): Fetcroja, cefiderocol, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0337/2024

EMEA-002106-PIP01-16-M03

Minutes of the CVMP meeting 15-17 July 2025

Opinion/decision on a Paediatric investigation plan (PIP): Ghryvelin (previously Macimorelin Aeterna Zentaris), Macimorelin, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrine disorders, PIP number: P/0331/2024