EMEA-001855-PIP01-15-M05 - paediatric investigation plan

fitusiran

Key facts

• Active Substance:
  fitusiran
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0410/2023
• PIP number:
  EMEA-001855-PIP01-15-M05
• 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:
  27/10/2023

Decision

P/0410/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fitusiran (EMEA- 001855-PIP01-15-M05)

AdoptedReference Number: EMA/429873/2023