EMEA-002765-PIP02-21-M01 - paediatric investigation plan
Ribociclib
PIPHuman
Key facts
- Invented name
- Kisqali
- Active Substance
- Ribociclib
- Therapeutic area
- Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Decision number
- P/0266/2024
- PIP number
- EMEA-002765-PIP02-21-M01
- Pharmaceutical form(s)
- Age appropriate oral liquid dosage formulation
- Film-coated tablet
- Condition(s) / indication(s)
- Treatment of neuroblastoma
- 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