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 specifically in adults 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/126.58 KB)
First published: 26/02/2014
Last updated: 11/12/2020
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||
24/11/2020 Tecfidera - EMEA/H/C/002601 - II/0063
- 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
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Antineoplastic and immunomodulating agents
Treatment of adult patients with relapsing remitting multiple sclerosis.