Xarelto

RSS

rivaroxaban

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

Overview

This is a summary of the European public assessment report (EPAR) for Xarelto. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Xarelto.

For practical information about using Xarelto, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 14/08/2019

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
29
Date of issue of marketing authorisation valid throughout the European Union
30/09/2008
Contact address

51368 Leverkusen
Germany

Product information

01/07/2019 Xarelto - EMEA/H/C/000944 - PSUSA/00002653/201809

Contents

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

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

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 prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.

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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
8 ratings