EMEA-002016-PIP04-20 - paediatric investigation plan

alpelisib

Key facts

• Invented name:
  Piqray
• Active substance:
  alpelisib
• Therapeutic area:
  Oncology
• Decision number:
  P/0122/2021
• PIP number:
  EMEA-002016-PIP04-20
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  • Treatment of Fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of peritoneal carcinoma (excluding blastomas and sarcomas)
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/03/2021
• Compliance check done:
  No
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0122/2021: EMA decision of 17 March 2021 on the granting of a product specific waiver for alpelisib (Piqray), (EMEA-002016-PIP04-20)

Adopted Reference Number: EMA/96297/2021