P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0183/2024: EMA decision of 17 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ganaxolone (ZTALMY), (EMEA-002341-PIP02-23)