Oxbryta

Human medicines European public assessment report (EPAR): Yuvanci, macitentan,tadalafil, Date of authorisation: 27/09/2024, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Oncology, PIP number: P/0377/2023

Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi, Risankizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0391/2023

EMEA-001776-PIP03-17-M01

Opinion/decision on a Paediatric investigation plan (PIP): Rukobia, fostemsavir (tromethamine), decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0380/2023

Minutes of the HMPC meeting 22-24 July 2024

Outcome of written procedures finalised during the period from 04 June 2024 to 25 September 2024

Opinion/decision on a Paediatric investigation plan (PIP): Stelara, ustekinumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: P/0341/2023

EMEA-003319-PIP02-22