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Rivaroxaban

Generic Name
Rivaroxaban
Brand Names
Xarelto, Rivaroxaban Accord, Rivaroxaban Viatris (previously Rivaroxaban Mylan)
Drug Type
Small Molecule
Chemical Formula
C19H18ClN3O5S
CAS Number
366789-02-8
Unique Ingredient Identifier
9NDF7JZ4M3

Overview

Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.

Background

Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.

Indication

Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); to reduce risk of recurrent DVT and/or PE. Rivaroxaban is also indicated, in combination with aspirin, for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Its use is also not recommended in those with severe renal impairment (<30mL/min). Rivaroxaban is also indicated for the treatment and prevention of VTE in pediatric patients (from birth to 18 years of age) and for thromboprophylaxis in pediatric patients ≥2 years old with congenital heart disease following the Fontan procedure.

Associated Conditions

  • Cardiovascular Mortality
  • Deep Vein Thrombosis
  • Deep vein thrombosis recurrent
  • Major Adverse Cardiovascular Events
  • Myocardial Infarction
  • Pulmonary Embolism
  • Recurrent Pulmonary Embolism (Disorder)
  • Recurrent Venous Thromboembolism
  • Stroke
  • Systemic Embolism
  • Thrombosis
  • Venous Thromboembolism

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2022/10/10
Phase 4
Not yet recruiting
Sarmad Zahoor
2022/09/21
Not Applicable
Completed
2022/09/19
Phase 4
Recruiting
Chinese Academy of Medical Sciences, Fuwai Hospital
2022/08/25
Phase 2
Completed
2022/08/08
Phase 1
UNKNOWN
Doasense GmbH
2022/08/04
Phase 4
Not yet recruiting
2022/07/18
N/A
Completed
2022/07/08
Not Applicable
Recruiting
Chiayi Christian Hospital
2022/06/08
Phase 3
UNKNOWN
2022/06/01
Phase 3
Recruiting

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approval Number
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Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Rivaroxaban Tablets
国药准字HJ20181085
化学药品
片剂
11/30/2023
Rivaroxaban Tablets
国药准字H20213374
化学药品
片剂
5/19/2021
Rivaroxaban Tablets
国药准字H20213399
化学药品
片剂
5/19/2021
Rivaroxaban Tablets
国药准字H20203739
化学药品
片剂
12/29/2020
Rivaroxaban Tablets
国药准字H20213382
化学药品
片剂
5/19/2021
Rivaroxaban Tablets
国药准字H20213636
化学药品
片剂
8/12/2021
Rivaroxaban Tablets
国药准字H20247123
化学药品
片剂
6/7/2024
Rivaroxaban Tablets
国药准字H20223582
化学药品
片剂
8/10/2022
Rivaroxaban Tablets
国药准字H20223318
化学药品
片剂
5/18/2022
Rivaroxaban Tablets
国药准字H20223642
化学药品
片剂
8/30/2022

PPB Drug Approvals

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No PPB approvals found for this drug.
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