EXARANE (Juno Pharmaceuticals Pty Ltd)
Product name
EXARANE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
228 (255 working days)
Active ingredients
enoxaparin sodium
Registration type
New biosimilar medicine
Indication
- Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery.
- Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.
- Prevention of thrombosis in extra-corporeal circulation during haemodialysis.
- Treatment of established deep vein thrombosis.
- Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
- Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).