Rivaroxaban Accord is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults: - to treat deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occuring; - to prevent venous thromboembolism (VTE, the formation of blood clots in the veins) in patients who are undergoing surgery to replace a hip or knee; - to prevent stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in patients with non‑valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart); - to prevent atherothrombotic events (such as heart attack, stroke or death from heart disease) in patients: - after an acute coronary syndrome, when it is used with an antiplatelet medicine (which prevents the formation of blood clots). Acute coronary syndrome consists of conditions such as unstable angina (a severe type of chest pain) and heart attack; - at high risk of ischaemic events (problems caused by restricted blood supply) who have coronary artery disease (disease caused by obstructed blood supply to the heart muscle) or peripheral artery disease (disease caused by defective blood flow in the arteries). It is used with aspirin. Rivaroxaban Accord contains the active substance rivaroxaban. Rivaroxaban Accord is a ‘generic medicine’. This means that Rivaroxaban Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Xarelto.
Therapeutic Indication
### Therapeutic indication Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). **Adults** Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) **Paediatric population** Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. **Adults** Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) **Paediatric population** Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.
Therapeutic Area (MeSH)
ATC Code
B01AF01
ATC Item
rivaroxaban
Pharmacotherapeutic Group
Antithrombotic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| rivaroxaban | N/A | 利伐沙班 |
EMA Name
Rivaroxaban Accord
Medicine Name
Rivaroxaban Accord
Aliases
N/A