Lixiana

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edoxaban

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

Overview

Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:

  • to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as high blood pressure, diabetes, heart failure, having had a stroke or being 75 years old or over;
  • 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 re-occurring.

Lixiana contains the active substance edoxaban.

This EPAR was last updated on 04/10/2023

Authorisation details

Product details
Name
Lixiana
Agency product number
EMEA/H/C/002629
Active substance
edoxaban tosilate
International non-proprietary name (INN) or common name
edoxaban
Therapeutic area (MeSH)
  • Stroke
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01
Publication details
Marketing-authorisation holder
Daiichi Sankyo Europe GmbH
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
19/06/2015
Contact address

Zielstattstrasse 48
81379 Munich
Germany

Product information

26/07/2023 Lixiana - EMEA/H/C/002629 - PSUSA/00010387/202210

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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