Table of contents
Tecfidera is a medicine used to treat multiple sclerosis (MS), a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves. It is used in adults and children from 13 years of age with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Tecfidera contains the active substance dimethyl fumarate.
Tecfidera : EPAR - Medicine overview (PDF/112.97 KB)
First published: 26/02/2014
Last updated: 25/05/2022
Tecfidera : EPAR - Risk Management Plan (PDF/1.17 MB)
First published: 30/11/2022
|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||
Prins Mauritslaan 13
13/05/2022 Tecfidera - EMEA/H/C/002601 - II/0073
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 202225/02/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 January 202228/01/2022
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 201322/11/2013