Application Nr Approved Date Route Status External Links
NDA202439 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Xarelto Is A Factor Xa Inhibitor Indicated: To Reduce The Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation ( 1.1 ) For The Treatment Of Deep Vein Thrombosis (Dvt) ( 1.2 ) For The Treatment Of Pulmonary Embolism (Pe) ( 1.3 ) For The Reduction In The Risk Of Recurrence Of Dvt And/or Pe In Patients At Continued Risk For Recurrent Dvt And/or Pe After Completion Of Initial Treatment Lasting At Least 6 Months ( 1.4 ) For The Prophylaxis Of Dvt, Which May Lead To Pe In Patients Undergoing Knee Or Hip Replacement Surgery ( 1.5 ) In Combination With Aspirin, To Reduce The Risk Of Major Cardiovascular Events (Cardiovascular (Cv) Death, Myocardial Infarction (Mi) And Stroke) In Patients With Chronic Coronary Artery Disease (Cad) Or Peripheral Artery Disease (Pad) ( 1.6 ) 1.1 Reduction Of Risk Of Stroke And Systemic Embolism In Nonvalvular Atrial Fibrillation Xarelto Is Indicated To Reduce The Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation. There Are Limited Data On The Relative Effectiveness Of Xarelto And Warfarin In Reducing The Risk Of Stroke And Systemic Embolism When Warfarin Therapy Is Well-Controlled [See Clinical Studies (14.1) ]. 1.2 Treatment Of Deep Vein Thrombosis Xarelto Is Indicated For The Treatment Of Deep Vein Thrombosis (Dvt). 1.3 Treatment Of Pulmonary Embolism Xarelto Is Indicated For The Treatment Of Pulmonary Embolism (Pe). 1.4 Reduction In The Risk Of Recurrence Of Deep Vein Thrombosis And/or Pulmonary Embolism Xarelto Is Indicated For The Reduction In The Risk Of Recurrence Of Dvt And/or Pe In Patients At Continued Risk For Recurrent Dvt And/or Pe After Completion Of Initial Treatment Lasting At Least 6 Months. 1.5 Prophylaxis Of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery Xarelto Is Indicated For The Prophylaxis Of Dvt, Which May Lead To Pe In Patients Undergoing Knee Or Hip Replacement Surgery. 1.6 Reduction Of Risk Of Major Cardiovascular Events In Patients With Chronic Coronary Artery Disease (Cad) Or Peripheral Artery Disease (Pad) Xarelto, In Combination With Aspirin, Is Indicated To Reduce The Risk Of Major Cardiovascular Events (Cardiovascular (Cv) Death, Myocardial Infarction (Mi) And Stroke) In Patients With Chronic Coronary Artery Disease (Cad) Or Peripheral Artery Disease (Pad).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rivaroxaban RIVAROXABAN ZINC3964126

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