Key facts

Invented name
Zolgensma
Active Substance
Onasemnogene abeparvovec
Therapeutic area
Neurology
Decision number
P/0015/2022
PIP number
EMEA-002168-PIP01-17-M04
Pharmaceutical form(s)
Solution for injection/infusion
Condition(s) / indication(s)
Treatment of spinal muscular atrophy
Route(s) of administration
  • Intravenous use
  • Intrathecal use
Contact for public enquiries

Novartis Gene Therapy EU Limited

paediatric.enquiries@novartis.com

+41 613241111

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0015/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for onasemnogene abeparvovec (Zolgensma), (EMEA-002168-PIP01-17-M04)

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