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ACTIVE SUBSTANCE / INN

CABOZANTINIB

Brand name(s): Cometriq, RESNIBEN, Cabometyx, CABOZANTINIB
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
Thyroid Neoplasms
Carcinoma, Renal Cell;Carcinomas, Hepatocellular
ACTIVE SUBSTANCE
Cabozantinib
REGULATORS
FDA · EMA
SPONSORS / MAH
MSN LABORATORIES PRIVATE LTD, TEVA PHARMS INC, AZURITY
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RESNIBENNDA220258AZURITYPrescription
CABOZANTINIBANDA215942TEVA PHARMS INCPrescription
CABOZANTINIBANDA213878MSN LABORATORIES PRIVATE LTDNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
CometriqIpsen PharmaAuthorised21/03/2014Thyroid Neoplasms
CabometyxIpsen PharmaAuthorised09/09/2016Carcinoma, Renal Cell;Carcinomas, Hepatocellular

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