Xarelto® Indications

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The below overview respresents the approval status of Xarelto in the European Union (as approved by EMA). Doctors should always refer to their local product information for further detail on approved indication in their country.

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Stroke prevention in NVAF

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Xarelto is indicated for stroke prevention in adults with non-valvular atrial fibrillation with one or more risk factors

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Treatment of PE/DVT and prevention of recurrent VTE

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Xarelto is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DTV and PE in adults

Xarelto is indicated for the treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation

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Prevention of Atherothrombotic Events in Peripheral Artery Disease

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Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adults with symptomatic peripheral artery disease (PAD) at high risk of ischaemic events

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Prevention of Atherothrombotic Events in Coronary Artery Disease

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Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adults with coronary artery disease (CAD) at high risk of ischaemic events

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Secondary prevention in ACS

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Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after acute coronary syndrome with elevated cardiac biomarkers

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Prevention of VTE after elective hip replacement surgery

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The first approved indication for Xarelto was for the prevention of venous thromboembolism in adults undergoing elective hip replacement surgery

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Prevention of VTE after elective knee replacement surgery

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The first approved indication for Xarelto was for the prevention of venous thromboembolism in adults undergoing elective knee replacement surgery

PP-XAR-ALL-1787-2


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       Xarelto® (rivaroxaban) Summary of Product Characteristics.