EMA/PE/0000180736 - paediatric investigation plan

brogidirsen

Key facts

• Active substance:
  brogidirsen
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  EMA/PE/0000180736
• PIP number:
  EMA/PE/0000180736
• Pharmaceutical form(s):
  • Solution for injection
  • 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)
• Decision date:
  12/06/2025
• Compliance check done:
  Ei

Decision

EMA/PE/0000180736 : EMA decision of 12 June 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Brogidirsen

Adopted Reference Number: EMADOC-1700519818-2194541