EMEA-002705-PIP01-19-M02 - paediatric investigation plan
Iptacopan
PIPHuman
Key facts
- Active Substance
- Iptacopan
- Therapeutic area
- Renal and urinary disorders
- Decision number
- P/0222/2024
- PIP number
- EMEA-002705-PIP01-19-M02
- Pharmaceutical form(s)
- Capsule, hard
- Age appropriate oral solid dosage form
- Condition(s) / indication(s)
- Treatment of C3 glomerulopathy
- Route(s) of administration
- Oral use
- Contact for public enquiries
Novartis Europharm Limited
E-mail: paediatric.enquiries@novartis.com
Tel. +41 613241111- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date