RIVALEM (Alembic Pharmaceuticals Australia Pty Ltd)
Product name
RIVALEM
Date registered
Evaluation commenced
Decision date
Approval time
120 (255 working days
Active ingredients
Rivaroxaban
Registration type
New generic medicine
Indication
Rivalem is indicated for:
- Prevention of venous thromboembolism (VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks)
- Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE
Rivalem, in combination with aspirin, is indicated for:
- The prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD)