EMEA-002362-PIP02-19-M03 - paediatric investigation plan

fidanacogene elaparvovec

Key facts

• Active substance:
  fidanacogene elaparvovec
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0115/2024
• PIP number:
  EMEA-002362-PIP02-19-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of congenital factor IX deficiency (haemophilia B)
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0115/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fidanacogene elaparvovec (EMEA-002362-PIP02-19-M03)

Adopted Reference Number: EMA/121937/2024