EMEA-002016-PIP04-20 - paediatric investigation plan

Alpelisib
PIPHuman

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
Contact for public enquiries

Novartis Europharm Limited

E-mail: paediatric.enquiries@novartis.com
Tel. +41 6132 46715

Decision type
W: decision granting a waiver in all age groups for all conditions or indications
Decision date
Compliance opinion date
Compliance outcome
Positive

Decision

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