EMEA-002168-PIP01-17-M06 - paediatric investigation plan

onasemnogene abeparvovec

Key facts

• Invented name:
  Zolgensma
• Active substance:
  onasemnogene abeparvovec
• Therapeutic area:
  Neurology
• Decision number:
  P/0149/2024
• PIP number:
  EMEA-002168-PIP01-17-M06
• Pharmaceutical form(s):
  Solution for injection/infusion
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  • Intravenous use
  • Intrathecal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/05/2024
• Compliance check done:
  Ne

Decision

P/0149/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for onasemnogene abeparvovec (Zolgensma), (EMEA-002168-PIP01-17-M06)

Adopted Reference Number: EMA/155951/2024