EMEA-001911-PIP02-22-M01 - paediatric investigation plan
inebilizumab
PIPHuman
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Key facts
- Invented name
- Uplizna
- Active substance
- inebilizumab
- Therapeutic area
- Nervous system disorders
- Decision number
- P/0206/2024
- PIP number
- EMEA-001911-PIP02-22-M01
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of myasthenia gravis
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Horizon Therapeutics Ireland DAC
E-mail: medinfointernational@amgen.com
Tel. +44 (0)1223420305- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Όχι