EMEA-002016-PIP03-19-M02 - paediatric investigation plan

Alpelisib
PIPHuman

Key facts

Invented name
Piqray
Active Substance
Alpelisib
Therapeutic area
Other
Decision number
P/0412/2022
PIP number
EMEA-002016-PIP03-19-M02
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules
Condition(s) / indication(s)
Treatment of PIK3CA related overgrowth spectrum
Route(s) of administration
Oral use
Contact for public enquiries

Novartis Europharm Limited

E-mail: paediatric.enquiries@novartis.com
Tel. +41 6132 41111

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

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