EMEA-002724-PIP01-19-M03 - paediatric investigation plan

Giroctocogene fitelparvovec

Key facts

• Active substance:
  Giroctocogene fitelparvovec
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0164/2024
• PIP number:
  EMEA-002724-PIP01-19-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• 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:
  06/05/2024
• Compliance check done:
  No

Decision

P/0164/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for giroctocogene fitelparvovec (EMEA-002724-PIP01-19-M03)

Adopted Reference Number: EMA/176730/2024