ACTIVE SUBSTANCE / INN

ALPELISIB

Brand name(s): Piqray, VIJOICE, PIQRAY, Vijoice
FDA LISTED
EMA LISTED
PRESCRIPTION
APPLICATION WITHDRAWN
AUTHORISED
Breast Neoplasms
NDA218466
ACTIVE SUBSTANCE
Alpelisib
REGULATORS
FDA · EMA
SPONSORS / MAH
NOVARTIS, Novartis Europharm Limited
TOTAL APPLICATIONS
4
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
VIJOICENDA218466NOVARTISPrescription
PIQRAYNDA212526NOVARTISPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
PiqrayNovartis Europharm LimitedAuthorised27/07/2020Breast Neoplasms
VijoiceNovartis Europharm LimitedApplication withdrawnGenetic Diseases, Inborn;Growth Disorders

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