EMA/PE/0000228269 - paediatric investigation plan

garetosmab

Key facts

• Active substance:
  garetosmab
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0103/2024
• PIP number:
  EMA/PE/0000228269
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of fibrodysplasia ossificans progressiva
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  15/04/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000228269: EMA decision of 15 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for garetosmab

Adopted Reference Number: EMADOC-1700519818-2039917