EMEA-001855-PIP01-15-M06 - paediatric investigation plan

fitusiran

Key facts

• Active substance:
  fitusiran
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0285/2024
• PIP number:
  EMEA-001855-PIP01-15-M06
• 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:
  16/08/2024
• Compliance check done:
  No

Decision

P/0285/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fitusiran (EMEA-001855-PIP01-15-M06)

Adopted Reference Number: EMA/343724/2024