P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Compliance procedure number
EMEA-C-002932-PIP02-21
Compliance opinion date
Compliance outcome
Positive
Decision
P/0007/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for vorasidenib (as hemicitrate, hemihydrate salt) (EMEA-002932-PIP02-21)