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ACTIVE SUBSTANCE / INN

EVEROLIMUS

Brand name(s): Votubia, EVEROLIMUS, AFINITOR DISPERZ, ZORTRESS, AFINITOR, Afinitor
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Carcinoma, Renal Cell;Breast Neoplasms;Pancreatic Neoplasms
ANDA207934
ACTIVE SUBSTANCE
Everolimus
REGULATORS
FDA · EMA
SPONSORS / MAH
PH HEALTH, NOVARTIS, NOVARTIS PHARM
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
EVEROLIMUSANDA205432BRECKENRIDGEPrescription
EVEROLIMUSANDA207934PH HEALTHDiscontinued
AFINITOR DISPERZNDA203985NOVARTIS PHARMPrescription
ZORTRESSNDA021560NOVARTISPrescription
AFINITORNDA022334NOVARTISPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AfinitorNovartis Europharm LimitedAuthorised02/08/2009Carcinoma, Renal Cell;Breast Neoplasms;Pancreatic Neoplasms
VotubiaNovartis Europharm LimitedAuthorised02/09/2011Tuberous Sclerosis

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