EMEA-002168-PIP01-17-M05 - paediatric investigation plan

Onasemnogene abeparvovec

Key facts

• Invented name:
  Zolgensma
• Active Substance:
  Onasemnogene abeparvovec
• Therapeutic area:
  Neurology
• Decision number:
  P/0412/2023
• PIP number:
  EMEA-002168-PIP01-17-M05
• 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:
  27/10/2023

Decision

P/0412/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for onasemnogene abeparvovec (Zolgensma), (EMEA-002168-PIP01-17-M05)

AdoptedReference Number: EMA/429976/2023