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.
Roteas : EPAR - Summary for the public (PDF/75.87 KB)
First published: 04/05/2017
Last updated: 04/05/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Daiichi Sankyo Europe GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
25/07/2018 Roteas - EMEA/H/C/004339 - PSUSA/00010387/201710
- 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
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
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.