Application Nr Approved Date Route Status External Links
NDA022512 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pradaxa Is A Direct Thrombin Inhibitor Indicated: To Reduce The Risk Of Stroke And Systemic Embolism In Patients With Non-Valvular Atrial Fibrillation ( 1.1 ) For The Treatment Of Deep Venous Thrombosis (Dvt) And Pulmonary Embolism (Pe) In Patients Who Have Been Treated With A Parenteral Anticoagulant For 5-10 Days ( 1.2 ) To Reduce The Risk Of Recurrence Of Dvt And Pe In Patients Who Have Been Previously Treated ( 1.3 ) For The Prophylaxis Of Dvt And Pe In Patients Who Have Undergone Hip Replacement Surgery ( 1.4 ) 1.1 Reduction Of Risk Of Stroke And Systemic Embolism In Non-Valvular Atrial Fibrillation Pradaxa Is Indicated To Reduce The Risk Of Stroke And Systemic Embolism In Patients With Non-Valvular Atrial Fibrillation. 1.2 Treatment Of Deep Venous Thrombosis And Pulmonary Embolism Pradaxa Is Indicated For The Treatment Of Deep Venous Thrombosis And Pulmonary Embolism In Patients Who Have Been Treated With A Parenteral Anticoagulant For 5-10 Days. 1.3 Reduction In The Risk Of Recurrence Of Deep Venous Thrombosis And Pulmonary Embolism Pradaxa Is Indicated To Reduce The Risk Of Recurrence Of Deep Venous Thrombosis And Pulmonary Embolism In Patients Who Have Been Previously Treated. 1.4 Prophylaxis Of Deep Vein Thrombosis And Pulmonary Embolism Following Hip Replacement Surgery Pradaxa Is Indicated For The Prophylaxis Of Deep Vein Thrombosis And Pulmonary Embolism, In Patients Who Have Undergone Hip Replacement Surgery.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dabigatran Etexilate Mesylate

Comments