EMA/PE/0000233797 - paediatric investigation plan

delandistrogene moxeparvovec

Key facts

• Active substance:
  delandistrogene moxeparvovec
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0325/2023
• PIP number:
  EMA/PE/0000233797
• Pharmaceutical form(s):
  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:
  21/03/2025
• Compliance check done:
  Nu

Decision

EMA/PE/0000233797: EMA decision of 21 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for delandistrogene moxeparvovec

Adopted Reference Number: EMADOC-1700519818-1976248