EMEA-001911-PIP03-23-M01 - paediatric investigation plan
Inebilizumab
PIPHuman
Key facts
- Invented name
- Uplizna
- Active Substance
- Inebilizumab
- Therapeutic area
- Immune system disorders
- Surgical and medical procedures
- Decision number
- P/0217/2024
- PIP number
- EMEA-001911-PIP03-23-M01
- Pharmaceutical form(s)
- Concentrate for solution for infusion
- Condition(s) / indication(s)
- Treatment of immunoglobulin G4-related disease
- Route(s) of administration
- Intravenous use
- Contact for public enquiries
Horizon Therapeutics Ireland Designated Activity Company
Tel. +44 (0)1223420305
E-mail: medinfointernational@amgen.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date