Lixiana

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edoxaban

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

Overview

This is a summary of the European public assessment report (EPAR) for Lixiana. 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 Lixiana.

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

This EPAR was last updated on 10/07/2019

Authorisation details

Product details
Name
Lixiana
Agency product number
EMEA/H/C/002629
Active substance
edoxaban tosylate
International non-proprietary name (INN) or common name
edoxaban
Therapeutic area (MeSH)
  • Stroke
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01
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
Daiichi Sankyo Europe GmbH
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address
Zielstattstrasse 48
81379 München
Gerrmany

Product information

21/06/2019 Lixiana - EMEA/H/C/002629 - IAIN/0022

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 stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

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

Assessment history

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