EMEA-002341-PIP02-23 - paediatric investigation plan

ganaxolone

Key facts

• 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:
  • Oral use
  • Gastric use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  17/05/2024
• Compliance check done:
  Nej

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)

Adopted Reference Number: EMA/226610/2024