EMEA-003305-PIP01-22 - paediatric investigation plan

vesleteplirsen

Key facts

• Active substance:
  vesleteplirsen
• Therapeutic area:
  Neurology
• Decision number:
  P/0333/2023
• PIP number:
  EMEA-003305-PIP01-22
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Duchenne muscular dystrophy
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Compliance check done:
  No

Decision

P/0333/2023 : EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vesleteplirsen, (EMEA-003305-PIP01-22)

Reference Number: EMA/351272/2023