This is a summary of the European public assessment report (EPAR) for Tecfidera. 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 Tecfidera.
For practical information about using Tecfidera, patients should read the package leaflet or contact their doctor or pharmacist.
Tecfidera : EPAR - Summary for the public (PDF/78.83 KB)
First published: 26/02/2014
Last updated: 26/02/2014
Tecfidera : EPAR - Risk-management-plan summary (PDF/504.61 KB)
First published: 17/02/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Biogen Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
30/01/2020 Tecfidera - EMEA/H/C/002601 - II/0058
- 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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Antineoplastic and immunomodulating agents
Treatment of adult patients with relapsing remitting multiple sclerosis.