EMEA-002677-PIP01-19-M03 - paediatric investigation plan

delandistrogene moxeparvovec

Key facts

• Active substance:
  delandistrogene moxeparvovec
• Therapeutic area:
  Neurology
• Decision number:
  P/0325/2023
• PIP number:
  EMEA-002677-PIP01-19-M03
• 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:
  08/08/2023
• Compliance check done:
  No

Decision

P/0325/2023 : EMA decision of 8 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for delandistrogene moxeparvovec, (EMEA-002677-PIP01-19-M03)

Reference Number: EMA/344540/2023