Market Authorisation Date: 01 July, 2011

Treatment: Reducing the risk of stroke and systemic embolism; Treatment of pulmonary embolism (pe); Treatment of deep vein thrombosis (dvt); Reduction of risk of major cardiovascular events (cv death, mi, and stroke) in chronic cad or pad; Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding; Prophylaxis of thromboembolic diseases in pediatric patients aged 2 years and older with congenital heart disease who have undergone the fontan procedure and a body weight of >=50 kg; Treatment of venous thromboembolism (vte) and the reduction in the risk of recurrent vte in pediatric patients from birth to less than 18 years with a body weight of 30 kg to 49.9 kg after at least 5 days of initial parenteral anticoagulant treatment; Reduction in the risk of recurrence of deep vein thrombosis (dvt) and/or pulmonary embolism (pe) in patients at continued risk for recurrent dvt and/or after completion of initial treatment lasting at least 6 months; Prophylaxis of deep vein thrombosis (dvt); Reduction of risk of major cardiovascular events (cardiovascular death, myocardial infarction and stroke) in patients with cad; Reduction of risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of vascular etiology) in patients with pad; Treatment of venous thromboembolism (vte) and the reduction in the risk of recurrent vte in pediatric patients from birth to less than 18 years with a body weight of >=50 kg after at least 5 days of initial parenteral anticoagulant treatment; Treatment of pulmonary embolism with once daily, rapid-release tablet administered for at least five consecutive days; Treatment of deep vein thrombosis with once daily, rapid-release tablet administered for at least five consecutive days; Prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery, with once daily, rapid-release tablet administered for at least five consecutive days; Reduce the risk of stroke in patients with nonvalvular atrial fibrillation with once daily, rapid-release tablet administered for at least five consecutive days; Prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding with once daily, rapid-release tablet administered for at least 5 consecutive days; Treatment of dvt and/or pe and reduction in the risk of recurrent dvt and/or pe in pediatric patients (>=50 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after at least 5 days parenteral anticoagulant treatment; After completion of initial treatment lasting at least 6 months, to reduce the risk of recurrence of deep vein thrombosis and/or pulmonary embolism in certain patients with once daily, rapid-release tablet administered for at least 5 consecutive days; Prophylaxis of pe, dvt and/or stroke in pediatric patients (>=50 kg) aged 2 years and older with congenital heart disease after fontan procedure with once daily, rapid-release tablet administered for at least 5 consecutive days; Treatment of dvt and/or pe and reduction in risk of recurrent dvt and/or pe in pediatric patients (30-49.9 kg) once daily with rapid-release tablet administered for at least 5 consecutive days after at least 5 days parenteral anticoagulant treatment; Reduction of risk of cardiovascular death, myocardial infarction, and stroke in patients with cad by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily; Reduction of risk of myocardial infarction and ischemic stroke in patients with pad by administering clinically proven effective amounts that are 2.5 mg rivaroxaban twice daily and 75-100 mg aspirin daily

Dosage: TABLET;ORAL