RIVAROXABAN DR.REDDY'S/RIVAROXABAN-REDDY'S/ RIVAROXABAN-DRLA/ RIVAROXABAN-RZ (Dr Reddys Laboratories Australia Pty Ltd)
Product name
RIVAROXABAN DR.REDDY'S/RIVAROXABAN-REDDY'S/ RIVAROXABAN-DRLA/ RIVAROXABAN-RZ
Date registered
Evaluation commenced
Decision date
Approval time
169 (255 working days)
Active ingredients
Rivaroxaban
Registration type
New generic medicine
Indication
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 an PE.