Opinion/decision on a Paediatric investigation plan (PIP): Ztalmy, Ganaxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0183/2024

Published 1 day ago• 1 minute read

Invented name: Ztalmy
Active Substance: Ganaxolone
Therapeutic area: Congenital, familial and genetic disorders
Decision number: P/0183/2024
PIP number: EMEA-002341-PIP02-23
Pharmaceutical form(s): Oral suspension
Condition(s) / indication(s): Treatment of tuberous sclerosis complex
Route(s) of administration
Contact for public enquiries
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date