EMEA-001625-PIP02-21-M03 - paediatric investigation plan
satralizumab
PIPHuman
Key facts
- Invented name
- Enspryng
- Active Substance
- satralizumab
- Therapeutic area
- Nervous system disorders
- Neurology
- Decision number
- P/0069/2024
- PIP number
- EMEA-001625-PIP02-21-M03
- Pharmaceutical form(s)
- Solution for injection
- Condition(s) / indication(s)
- Treatment of myasthenia gravis
- Route(s) of administration
- Subcutaneous use
- Contact for public enquiries
Roche Registration GmbH
E-mail: global.eu_regulatory_office@roche.com
Tel. +49 7624142892- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date