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ACTIVE SUBSTANCE / INN

AXITINIB

Brand name(s): INLYTA, Inlyta, Axitinib Accord, AXITINIB
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NONE (TENTATIVE APPROVAL)
Carcinoma, Renal Cell
NDA202324
ACTIVE SUBSTANCE
Axitinib
REGULATORS
FDA · EMA
SPONSORS / MAH
PF PRISM CV, TEVA PHARMS, Pfizer Europe MA EEIG
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
AXITINIBANDA211650APOTEXPrescription
INLYTANDA202324PF PRISM CVPrescription
AXITINIBANDA210234TEVA PHARMSNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Axitinib AccordAccord Healthcare S.L.U.Authorised19/09/2024Carcinoma, Renal Cell
InlytaPfizer Europe MA EEIGAuthorised03/09/2012Carcinoma, Renal Cell

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