EMA/PE/0000229973 - paediatric investigation plan

fosigotifator sodium tromethamine

Key facts

• Active substance:
  fosigotifator sodium tromethamine
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000229973
• PIP number:
  EMA/PE/0000229973
• 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:
  07/04/2025
• Compliance check done:
  No

Decision

EMA/PE/0000229973 : EMA decision of 07 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for fosigotifator sodium tromethamine

Adopted Reference Number: EMADOC-1700519818-2040316