EMEA-002341-PIP01-18-M03 - paediatric investigation plan

ganaxolone

Key facts

• Invented name:
  Ztalmy
• Active substance:
  ganaxolone
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0350/2024
• PIP number:
  EMEA-002341-PIP01-18-M03
• Pharmaceutical form(s):
  • Oral suspension
  • Age appropriate oral liquid dosage 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:
  27/09/2024
• Compliance check done:
  No

Decision

P/0350/2024 : EMA decision of 27 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ganaxolone (Ztalmy), (EMEA-002341-PIP01-18-M03)

Adopted Reference Number: EMA/441673/2024