CIP RIVAROXABAN (Cipla Australia Pty Ltd)
Product name
CIP RIVAROXABAN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
116 (255 working days)
Active ingredients
Rivaroxaban
Registration type
New generic medicine
Indication
CIP RIVAROXABAN 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