RIVAXIB (Alphapharm Pty Ltd)
Product name
RIVAXIB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
154 (255 working days
Active ingredients
rivaroxaban
Registration type
New generic medicine
Indication
RIVAXIB is indicated for:
the 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)
the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke
the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE