EMEA-002326-PIP04-20-M01 - paediatric investigation plan

concizumab

Key facts

• Active Substance:
  concizumab
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0358/2023
• PIP number:
  EMEA-002326-PIP04-20-M01
• Pharmaceutical form(s):
  Solution for injection in pre-filled pen
• Condition(s) / indication(s):
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023

Decision

P/0358/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for concizumab (EMEA-002326-PIP04-20-M01)

Reference Number: EMA/347165/2023