EMEA-002341-PIP01-18-M02 - paediatric investigation plan

Ganaxolone

Key facts

• Active Substance:
  Ganaxolone
• Therapeutic area:
  Neurology
• Decision number:
  P/0404/2021
• PIP number:
  EMEA-002341-PIP01-18-M02
• Pharmaceutical form(s):
  • Oral suspension
  • Age-appropriate oral liquid formulation
• Condition(s) / indication(s):
  Treatment of cyclin-dependent kinase-like 5 deficiency disorder
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  01/10/2021

Decision

P/0404/2021: EMA decision of 1 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ganaxolone ,(EMEA- 002341-PIP01-18-M02)

Reference Number: EMA/533199/2021