This is a summary of the European public assessment report (EPAR) for Aubagio. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Aubagio.
Aubagio : EPAR - Summary for the public (PDF/86.23 KB)
First published: 06/09/2013
Last updated: 25/01/2016
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28/05/2018 Aubagio - EMEA/H/C/002514 - R/0016
- 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.
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Treatment of adult patients with relapsing-remitting multiple sclerosis (MS).