EMEA-002016-PIP05-23 - paediatric investigation plan
Alpelisib
PIPHuman
Key facts
- Invented name
- Piqray
- Active Substance
- Alpelisib
- Therapeutic area
- Congenital, familial and genetic disorders
- Decision number
- P/0090/2024
- PIP number
- EMEA-002016-PIP05-23
- Pharmaceutical form(s)
- Film-coated tablet
- Age-appropriate formulation
- Condition(s) / indication(s)
- Treatment of lymphatic malformations associated with a PIK3CA mutation
- Route(s) of administration
- Oral use
- Contact for public enquiries
Novartis Europharm Limited
E-mail: paediatric.enquiries@novartis.com
Tel. +41 613241111- Decision type
- P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
- Decision date