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 tosilate
|
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 |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
19/06/2015
|
Contact address |
Zielstattstrasse 48 |
Product information
17/05/2023 Lixiana - EMEA/H/C/002629 - N/0048
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.