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

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
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
Compliance Check Decision Date
Compliance opinion date
Compliance Check Procedure Number
Compliance procedure number

Decision Document

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