MHRA-100806-PIP01-22

Key Facts

Active Substance
Active Substance:
  • ALPELISIB
Invented Name
  • Piqray
  • Piqray
PIP Number MHRA-100806-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
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 24/08/2023