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ACTIVE SUBSTANCE / INN

RIVAROXABAN

Brand name(s): Rivaroxaban Viatris (previously Rivaroxaban Mylan), Rivaroxaban Koanaa, Rivaroxaban Accord, XARELTO, Xarelto, RIVAROXABAN
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA215859
Acute Coronary Syndrome;Coronary Artery Disease;Peripheral A…
ACTIVE SUBSTANCE
Rivaroxaban
REGULATORS
FDA · EMA
SPONSORS / MAH
LUPIN LTD, Bayer AG, INVAGEN PHARMS
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RIVAROXABANANDA208543INVAGEN PHARMSDiscontinued
RIVAROXABANANDA208555LUPIN LTDPrescription
XARELTONDA215859JANSSEN PHARMSPrescription
RIVAROXABANANDA212220MYLAN PHARMS INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Rivaroxaban KoanaaKoanaa Healthcare GmbHAuthorised21/11/2025Venous Thromboembolism;Pulmonary Embolism;Venous Thrombosis;Stroke;Embolism
Rivaroxaban Viatris (previously Rivaroxaban Mylan)Viatris LimitedAuthorised12/11/2021Venous Thromboembolism;Pulmonary Embolism;Acute Coronary Syndrome;Stroke;Coronar…
Rivaroxaban AccordAccord Healthcare S.L.U.Authorised16/11/2020Acute Coronary Syndrome;Coronary Artery Disease;Peripheral Arterial Disease;Veno…
XareltoBayer AGAuthorised30/09/2008Arthroplasty, Replacement;Venous Thromboembolism

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