Page contents Key factsDecisionRelated medicine informationTopicsKey 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 LimitedE-mail: paediatric.enquiries@novartis.comTel. +41 6132 46715 Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 17/03/2021 Compliance opinion date 20/09/2019 Compliance outcome Positive DecisionP/0122/2021: EMA decision of 17 March 2021 on the granting of a product specific waiver for alpelisib (Piqray), (EMEA-002016-PIP04-20)AdoptedReference Number: EMA/96297/2021 English (EN) (201.47 KB - PDF)First published: 05/11/2021ViewRelated medicine informationPiqrayTopicsPaediatricsShare this page