MHRA-100727-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ALPELISIB
Invented Name
  • Vijoice
  • Piqray
  • Vijoice
PIP Number MHRA-100727-PIP01-22-M01 (update)
Pharmaceutical form(s)
  • Film-coated tablet
  • Granules
Therapeutic area
Therapeutic area:
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
Conditions / Indications
Conditions / Indications:
  • Treatment of PIK3CA related overgrowth spectrum
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ALPELISIB.pdf
Published Date 30/06/2023