Roteas 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.
Roteas contains the active substance edoxaban.
This medicine is the same as Lixiana, which is already authorised in the European Union (EU). The company that makes Lixiana has agreed that its scientific data can be used for Roteas (‘informed consent’).
Roteas : EPAR - Medicine overview (PDF/153.16 KB)
First published: 04/05/2017
Last updated: 16/09/2020
Roteas : EPAR - Risk management plan summary (PDF/322.73 KB)
First published: 04/10/2023
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Glienicker Weg 125
09/08/2023 Roteas - EMEA/H/C/004339 - PSUSA/00010387/202210
This medicine’s product information is available in all official EU languages.
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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.
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.