EMEA-002741-PIP01-20-M02 - paediatric investigation plan

fordadistrogene movaparvovec

Key facts

• Active substance:
  fordadistrogene movaparvovec
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0073/2024
• PIP number:
  EMEA-002741-PIP01-20-M02
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/03/2024
• Compliance check done:
  No

Decision

P/0073/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fordadistrogene movaparvovec (EMEA-002741-PIP01-20-M02)

Adopted Reference Number: EMA/28205/2024