EMA/PE/0000242247 - paediatric investigation plan

fitusiran

Key facts

• Active substance:
  fitusiran
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000242247
• PIP number:
  EMA/PE/0000242247
• Pharmaceutical form(s):
  Subcutaneous use
• Condition(s) / indication(s):
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
• Route(s) of administration:
  Solution for injection
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/06/2025
• Compliance check done:
  Ne

Decision

EMA/PE/0000242247 : EMA decision of 13 June 2025 on the acceptance of a modification of an agreed paediatric investigation plan for fitusiran

Adopted Reference Number: EMADOC-1700519818-2192643