Tecfidera

RSS

dimethyl fumarate

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

Overview

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.

This EPAR was last updated on 11/10/2018

Authorisation details

Product details
Name
Tecfidera
Agency product number
EMEA/H/C/002601
Active substance
dimethyl fumarate
International non-proprietary name (INN) or common name
dimethyl fumarate
Therapeutic area (MeSH)
Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
N07XX09
Publication details
Marketing-authorisation holder
Biogen Idec Ltd
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
30/01/2014
Contact address
Innovation House
70 Norden Road
Maidenhead
Berkshire SL6 4AY
United Kingdom

Product information

20/09/2018 Tecfidera - EMEA/H/C/002601 - R/0053

Contents

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Pharmacotherapeutic group

NERVOUS SYSTEM

Therapeutic indication

Treatment of adult patients with relapsing remitting multiple sclerosis.

Assessment history

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