RIVAROXABAN LUPIN/ RIVAROXABAN LAPL/ RIVAROXABAN GH (Lupin Australia Pty Limited)
Product name
RIVAROXABAN LUPIN/ RIVAROXABAN LAPL/ RIVAROXABAN GH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
176 (255 working days)
Active ingredients
rivaroxaban
Registration type
New generic medicine
Indication
- 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.
- Rivaroxaban Lupin, 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).