RIVAROXABAN SANDOZ (Sandoz Pty Ltd)
Product name
RIVAROXABAN SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
150 (255 working days)
Active ingredients
rivaroxaban
Registration type
New generic medicine
Indication
RIVAROXABAN SANDOZ (film coated tablet) 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 preention of recurrent DVT and PE.