CIP APIXABAN/ XABANIL/ APIXABAN CIPLA/ APIXAIR (Cipla Australia Pty Ltd)
Product name
CIP APIXABAN/ XABANIL/ APIXABAN CIPLA/ APIXAIR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
Apixaban
Registration type
New generic medicine
Indication
APIXABAN CIPLA/ XABANIL/ CIP APIXABAN/ APIXAIR is indicated for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery.
APIXABAN CIPLA/ XABANIL/ CIP APIXABAN/ APIXAIR is indicated for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.
APIXABAN CIPLA/ XABANIL/ CIP APIXABAN/ APIXAIR is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adult patients.
APIXABAN CIPLA/ XABANIL/ CIP APIXABAN/ APIXAIR is indicated for the prevention of recurrent DVT and PE in adult patients.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine