XARELTO- rivaroxaban tablet, film coated

JOM Pharmaceutical Services Inc.

XARELTO is a factor Xa inhibitor indicated:to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1)for treatment of deep vein thrombosis (DVT) ( 1.2)for treatment of pulmonary embolism (PE) ( 1.3)for reduction in the risk of recurrence of DVT or PE ( 1.4)for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5)for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6)to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7)to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8)for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9)for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10)

Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Do not freeze the granules or reconstituted suspension.