Lixiana
edoxaban
Table of contents
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.
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List item
Lixiana : EPAR - Medicine overview (PDF/143.36 KB)
First published: 03/07/2015
Last updated: 16/09/2020
EMA/481992/2020 -
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List item
Lixiana : EPAR - Risk-management-plan summary (PDF/75.85 KB)
First published: 03/07/2015
Last updated: 03/07/2015
EMA/279549/2015
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) |
|
Anatomical therapeutic chemical (ATC) code |
B01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Daiichi Sankyo Europe GmbH
|
Revision |
13
|
Date of issue of marketing authorisation valid throughout the European Union |
19/06/2015
|
Contact address |
Product information
26/11/2020 Lixiana - EMEA/H/C/002629 - WS/1922
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
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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.