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Dimethyl fumarate

Also known as: Tecfidera · Skilarence · Dimethyl fumarate Accord · Dimethyl fumarate Mylan · Dimethyl fumarate Neuraxpharm

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In short

In the European Union, dimethyl fumarate is indicated for the treatment of moderate to severe plaque psoriasis in adults who require systemic medicinal therapy. It is also indicated in the European Union for treating adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis. In the United States, dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis in adults, which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

From: Source: European Medicines Agency (EMA), Skilarence — EPAR, 17/03/2025. © European Medicines Agency. · Source: European Medicines Agency (EMA), Tecfidera — EPAR, 11/08/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
1373478 dimethyl fumarate
EMA
EMEA/H/C/002601, EMEA/H/C/002157, EMEA/H/C/006471, EMEA/H/C/006397, EMEA/H/C/006500

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) Dimethyl Fumarate

1 INDICATIONS AND USAGE Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )

Data provided by the U.S. Food and Drug Administration.

Document date: 20260603 · Official document →

EMA (EU) Skilarence

Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.

Source: European Medicines Agency (EMA), Skilarence — EPAR, 17/03/2025. © European Medicines Agency.

Document date: 17/03/2025 · Official document →

EMA (EU) Tecfidera

Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Source: European Medicines Agency (EMA), Tecfidera — EPAR, 11/08/2026. © European Medicines Agency.

Document date: 11/08/2026 · Official document →

Related terms in the cited sources

Has an official indication for

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External resources

Questions

What is Dimethyl fumarate approved for in the European Union?

Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. (Source: European Medicines Agency (EMA), Skilarence — EPAR, 17/03/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Skilarence — EPAR, 17/03/2025. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Tecfidera — EPAR, 11/08/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →