Edoxaban

Edoxaban is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

4 for haemodynamically unstable PE patients).

Sandoz Edoxaban (edoxaban tablets) is indicated for: • Prevention of stroke and systemic embolic events in patients with atrial fibrillation, in whom anticoagulation is appropriate. • Treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and PE.

1 Pediatrics (< 18 years of age) The safety and efficacy of edoxaban tablets in children under the age of 18 years have not yet been established. Therefore, use of Sandoz Edoxaban is not recommended in these patients. 2 Geriatrics (> 65 years of age) Clinical studies in stroke prevention in patients with atrial fibrillation (SPAF), treatment of VTE and prevention of recurrent DVT and PE, included patients > 65 years of age (see 7 WARNINGS AND PRECAUTIONS - Table 5, 4 DOSAGE AND ADMINISTRATION, and 14 CLINICAL TRIALS).

Roteas is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

4 for haemodynamically unstable PE patients). 3