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RIVAROXABAN SANDOZ (Sandoz Pty Ltd)

Product name
RIVAROXABAN SANDOZ
Sponsor
Sandoz Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
161 (255 working days)
Active ingredients
rivaroxaban
Registration type
New generic medicine
Indication

Rivaroxaban Sandoz is indicated for:

  • Prevention of venous thromboembolism (VTE) in adult patients who haveundergone major orthopaedic surgery of the lower limbs (elective total hipreplacement, 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 atrialfibrillation and at least one additional risk factor for stroke
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for theprevention of recurrent DVT and PE.

Rivaroxaban Sandoz, in combination with aspirin, is indicated for:

  • The prevention of major cardiovascular events (composite of stroke, myocardialinfarction and cardiovascular death) in patients with coronary artery disease (CAD)and/or peripheral artery disease (PAD)