Xarelto

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rivaroxaban

Authorised
This medicine is authorised for use in the European Union.

Overview

Xarelto is an anticoagulant medicine (a medicine that prevents blood clotting) used:

  • to treat deep vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from reccuring in adults;
  • to prevent venous thromboembolism (VTE, the formation of blood clots in the veins) in adults who are undergoing surgery to replace a hip or knee;
  • to treat VTE and prevent VTE from recurring in children and adolescents aged less than 18 years;
  • to prevent stroke (caused by a blood clot in the brain) and systemic embolism (a blood clot in another organ) in adults with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart);
  • to prevent atherothrombotic events (such as heart attack, stroke or death from heart disease) in adults:
    • after an acute coronary syndrome, when it is used with an antiplatelet medicine (which prevents the formation of blood clots). Acute coronary syndrome consists of conditions such as unstable angina (a severe type of chest pain) and heart attack;
    • at high risk of ischaemic events (problems caused by restricted blood supply) who have coronary artery disease (disease caused by obstructed blood supply to the heart muscle) or peripheral artery disease (disease caused by defective blood flow in the arteries). It is used with aspirin.

Xarelto contains the active substance rivaroxaban.

This EPAR was last updated on 13/07/2021

Authorisation details

Product details
Name
Xarelto
Agency product number
EMEA/H/C/000944
Active substance
rivaroxaban
International non-proprietary name (INN) or common name
rivaroxaban
Therapeutic area (MeSH)
  • Arthroplasty, Replacement
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01AF01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Bayer AG
Revision
34
Date of issue of marketing authorisation valid throughout the European Union
30/09/2008
Contact address

51368 Leverkusen
Germany

Product information

21/06/2021 Xarelto - EMEA/H/C/000944 - PSUSA/00002653/202009

Contents

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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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.

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.

Adults

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.

Paediatric population

Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Paediatric population

Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Assessment history

Changes since initial authorisation of medicine

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