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XARELTO (Bayer Australia Ltd)
Product name
XARELTO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
184 working days (255)
Active ingredients
rivaroxaban
Registration type
EOI
Indication
XARELTO (tablets), in combination with aspirin, is now also indicated for the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD).