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APIXABAN GH (Lupin Australia Pty Limited)
Product name
APIXABAN GH
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
159 (255 working days)
Active ingredients
apixaban
Registration type
New generic medicine
Indication
[TRADE NAME] is indicated for:
- the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery
- the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke
- the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients.
- the prevention of recurrent DVT and PE in adult patients.