RIVATOR (Torrent Australasia Pty Ltd)
Product name
RIVATOR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
135 (255 working days)
Active ingredients
rivaroxaban
Registration type
New generic medicine
Indication
- 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