Roteas

RSS

edoxaban

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

Overview

This is a summary of the European public assessment report (EPAR) for Roteas. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Roteas.

For practical information about using Roteas, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 01/10/2018

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
Daiichi Sankyo Europe GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
19/04/2017
Contact address
Zielstattstrasse 48
81379 Munich
Germany

Product information

25/07/2018 Roteas - EMEA/H/C/004339 - PSUSA/00010387/201710

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

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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