Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 07 September 2018

Indication(s)

- Xarelto 2.5 mg film-coated tablets:
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 an acute coronary syndrome (ACS) with elevated cardiac biomarkers.

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



- Xarelto 10 mg film-coated tablets:
Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.



- Xarelto 15 mg film-coated tablets
- Xarelto 20 mg film-coated tablets:

Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/000944
Orphan designation No
Date First Approved 30-09-2008
Type Medicinal product subject to medical prescription
Marketing authorisation holder Bayer AG
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions