Grumpy-XL schreef op 3 juli 2023 22:07:
www.ema.europa.eu/en/documents/agenda...Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 03-06 July 2023
5.1.2. Leniolisib - EMEA/H/C/005927, Orphan
Applicant: Pharming Technologies B.V.
Scope Treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)
Action: For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP