EMEA-002501-PIP01-18-M03 - paediatric investigation plan

Efanesoctocog alfa

Key facts

• Active substance:
  Efanesoctocog alfa
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0382/2022
• PIP number:
  EMEA-002501-PIP01-18-M03
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Treatment of Haemophilia A
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/10/2022
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-002501-PIP01-18-M03
• Compliance opinion date:
  26/04/2023
• Compliance outcome:
  Positive

Decision

P/0382/2022 : EMA decision of 10 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for efanesoctocog alfa (EMEA-002501-PIP01-18-M03)

Adopted Reference Number: EMA/709081/2022