EMEA-003344-PIP01-22-M01 - paediatric investigation plan

fosigotifator sodium tromethamine

Key facts

• Active substance:
  fosigotifator sodium tromethamine
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0306/2024
• PIP number:
  EMEA-003344-PIP01-22-M01
• Pharmaceutical form(s):
  • Age appropriate dosage form, other
  • Granules
• Condition(s) / indication(s):
  Treatment of vanishing white matter disease
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  16/08/2024
• Compliance check done:
  No

Decision

P/0306/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fosigotifator sodium tromethamine (EMEA-003344-PIP01-22-M01)

Adopted Reference Number: EMA/364886/2024