EMEA-001722-PIP01-14-M02 - paediatric investigation plan

eteplirsen

Key facts

• Active substance:
  eteplirsen
• Therapeutic area:
  Neurology
• Decision number:
  P/0286/2019
• PIP number:
  EMEA-001722-PIP01-14-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:
  16/08/2019
• Compliance check done:
  Nee

Decision

P/0286/2019: EMA decision of 16 August 2019 on the acceptance of a modification of an agreed paediatric investigation plan for eteplirsen, (EMEA- 001722-PIP01-14-M02)

Adopted Reference Number: EMA/440000/2019