Roteas

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edoxaban

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

Overview

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’).

This EPAR was last updated on 16/09/2020

Authorisation details

Product details
Name
Roteas
Agency product number
EMEA/H/C/004339
Active substance
edoxaban tosylate
International non-proprietary name (INN) or common name
edoxaban
Therapeutic area (MeSH)
  • Stroke
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01AF03
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
Berlin-Chemie AG
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
19/04/2017
Contact address

Glienicker Weg 125
12489 Berlin
Germany

Product information

25/06/2020 Roteas - EMEA/H/C/004339 - WS/1756

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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.

Assessment history

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