EMEA-002168-PIP01-17-M05 - paediatric investigation plan
Onasemnogene abeparvovec
PIPHuman
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
- Contact for public enquiries
- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date