Xarelto
rivaroxaban
Table of contents
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.
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List item
Xarelto : EPAR - Medicine overview (PDF/144.84 KB)
First published: 06/05/2009
Last updated: 02/02/2021
EMA/617633/2020 -
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List item
Xarelto : EPAR - Risk-management-plan summary (PDF/160.95 KB)
First published: 06/09/2018
Last updated: 06/09/2018
Authorisation details
Product details | |
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Name |
Xarelto
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Agency product number |
EMEA/H/C/000944
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Active substance |
rivaroxaban
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International non-proprietary name (INN) or common name |
rivaroxaban
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B01AF01
|
Additional 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 | |
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Marketing-authorisation holder |
Bayer AG
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Revision |
33
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Date of issue of marketing authorisation valid throughout the European Union |
30/09/2008
|
Contact address |
Product information
21/01/2021 Xarelto - EMEA/H/C/000944 - X/0074/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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27/07/2018
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05/02/2016
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18/12/2015
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22/03/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 201219/10/2012
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23/09/2011