MHRA-100450-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ALPELISIB
Invented Name
  • Piqray
  • Piqray
PIP Number MHRA-100450-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:
  • PIK3CA Related Overgrowth Spectrum (PROS)
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
Yes
Compliance Check Decision Date
Compliance opinion date
04/05/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100450-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ALPELISIB.pdf
Published Date 29/07/2022