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dimethyl fumarate

Skilarence, Tecfidera · ATC code L04AX07

Also known as: Dimethylfumarat · Brand names: Skilarence, Tecfidera, Balfumon, Dimethyl Fumarat Zentiva, Dimtelzo, Dimtruzic, Dimethyl Fumarate Piramal, Dimethylfumarate Macleods, Dimetilfumarato Cipla, Mustef, Nideolo, Onavuo, Difurat, Fumatil, Lidwina …

Key facts
Active substance
dimethyl fumarate
Drug class
Immunosuppressive drug
ATC code
L04AX07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Skilarence 30 mg gastro-resistant tablets / Skilarence 120 mg gastro-resistant tablets · Tecfidera 120 mg gastro-resistant hard capsules / Tecfidera 240 mg gastro-resistant hard capsules
Marketing authorisation holder
Almirall, S.A., Biogen Netherlands B.V.
Information as of
2026-10-27

Key facts

Dimethyl fumarate is a fumaric acid ester with immunomodulatory effects. Depending on the product it is used for moderate to severe plaque psoriasis (Skilarence) or relapsing remitting multiple sclerosis (Tecfidera).

What it is used for

  • Skilarence: moderate to severe plaque psoriasis in adults in need of systemic therapy
  • Tecfidera: relapsing remitting multiple sclerosis (RRMS) in adults and paediatric patients aged 13 years and older

Dosing

  • Skilarence: gradual start, first week 30 mg in the evening, week 2 twice daily, week 3 three times daily 30 mg; from the fourth week 120 mg in the evening, then increased by one 120 mg tablet per week; maximum 720 mg daily
  • Skilarence: after improvement, gradual reduction to the individual maintenance dose; tablets swallowed whole during or immediately after a meal
  • Tecfidera: start 120 mg twice a day, after 7 days maintenance 240 mg twice a day, taken with food
  • Tecfidera: temporary reduction to 120 mg twice a day may reduce flushing and GI reactions; resume maintenance within 1 month
  • Do not crush, divide or chew capsules or tablets

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Skilarence: severe gastrointestinal disorders, severe hepatic or renal impairment, pregnancy and breast-feeding
  • Tecfidera: suspected or confirmed progressive multifocal leukoencephalopathy (PML)

Important warnings

  • Lymphopenia and leukopenia may occur: blood count before and regularly during treatment; stop at marked decreases (thresholds in the full text)
  • Opportunistic infections, particularly PML, have been reported
  • Drug-induced liver injury possible; liver tests before starting and as clinically indicated
  • Monitor renal function; watch for Fanconi syndrome with Skilarence

Side effects

  • Tecfidera: most common flushing (35%) and GI events such as diarrhoea (14%), nausea (12%) and abdominal pain (10%), mainly in the first month
  • Skilarence: most common GI events, followed by flushing and lymphopenia
  • Serious: lymphopenia, PML, liver injury

Interactions

  • Skilarence: caution with other systemic antipsoriatics; avoid other fumaric acid derivatives; nephrotoxic substances increase the risk of renal adverse reactions
  • Tecfidera: caution with anti-neoplastic or immunosuppressive therapies
  • Vaccine information in the full text

Pregnancy and breastfeeding

  • Skilarence: contraindicated in pregnancy and breast-feeding; not recommended in women of child-bearing potential without appropriate contraception
  • Tecfidera: registry data on early pregnancy exposure indicate no malformative toxicity; risk of longer or later exposure is unknown

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • BalfumonG.L. Pharma Gmbh · 1 register entry
  • Dimethyl Fumarat ZentivaZentiva, K.S. · 1 register entry
  • Dimethylfumarat1a Pharma Gmbh, Ratiopharm Arzneimittel Vertriebs-Gmbh, Pharmathen S.A., Genericon Pharma Gesellschaft M.B.H., Actavis Group Ptc Ehf., Glenmark Arzneimittel Gmbh, +pharma Arzneimittel Gmbh, Sandoz Gmbh, Stada Arzneimittel Gmbh, Reddy Holding Gmbh · 13 register entries
  • DimtelzoSandoz Gmbh · 1 register entry
  • DimtruzicSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Dimethyl Fumarate PiramalAdalvo Limited · 1 register entry
  • Dimethylfumarat089pharm Gmbh, 1 A Pharma Gmbh, Pharmathen S.A., Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Genepharm S.A., Medical Valley Invest Ab, Glenmark Arzneimittel Gmbh, Macleods Pharma España, S.L.U, Heumann Pharma Gmbh & Co. Generica Kg, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Basics Gmbh, Biocon Pharma Malta I Limited, Aliud Pharma Gmbh, Cipla Europe Nv, Hexal Ag, Intas Third Party Sales 2005, S.L., Olpha As, Stadapharm Gmbh, Abdi Farma Gmbh, Betapharm Arzneimittel Gmbh, Qilu Pharma Spain S.L. · 26 register entries
  • Dimethylfumarate MacleodsMacleods Pharma España, S.L.U · 1 register entry
  • Dimetilfumarato CiplaCipla Europe Nv · 1 register entry
  • DimtelzoHexal Ag · 1 register entry
  • DimtruzicHexal Ag · 1 register entry
  • MustefAdalvo Limited · 1 register entry
  • NideoloPharmathen · 1 register entry
  • OnavuoHexal Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • DifuratGENVEON İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • FumatilKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 3 register entries
  • LidwinaALİ RAİF İLAÇ SAN. A.Ş. · 3 register entries
  • PharonSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • TecdimexTEVA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • TecfideraBİOGEN TURKEY İLAÇ TİC. LTD. ŞTİ. · 3 register entries
  • TenipraABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Dimethyl Fumarate, Dimtelzo, Dimtruzic
Bulgaria
Arbicen, Dimethyl Fumarate Msn, Джакстеран, Диметилфумарат G.L. Pharma, Диметилфумарат Гедеон Рихтер, Диметилфумарат Сандоз, Диметилфумарат Тева Фарма, Димтелзо, Димтрузик, Димфорда, Доприлад, Кохибер
Croatia
Dimethylfumarat Qilu, Dimetilfumarat, Dimtelzo, Dimtruzic, Ditagfenda, Jaxteran, Xynito
Cyprus
Dimethyl Fumarate Ebewe, Dimethyl Fumarate Hemopharm, Dimethyl Fumarate Msn, Dimethyl Fumarate Sandoz, Dimethyl Fumarate Stada, Dimethyl Fumarate Teva, Dimethyl Fumarate/Stada, Lafadera, Scleryda
Czechia
Adifemu, Cohiber, Dimethyl Fumarate Abdi, Dimethyl Fumarate Cipla, Dimethyl Fumarate Gedeon Richter, Dimethyl Fumarate Glenmark, Dimethyl Fumarate Msn, Dimethyl Fumarate Olpha, Dimethyl Fumarate Sandoz, Dimethyl Fumarate Stada Arzneimittel Ag, Dimethyl Fumarate Teva Cr, Dimethyl Fumarát Teva Gmbh, Dimforda, Dimtelzo, Dimtruzic, Jaxteran, Noroplex
Denmark
Dimethyl Fumarate, Dimethylfumarat "pharmathen", Dimforda
Estonia
Dimethyl Fumarate, Dimtelzo, Dimtruzic, Fosclera
Finland
Dimethyl Fumarate, Dimetylfumarat Avansor, Dimforda
France
Dimethyl Fumarate Arrow, Dimethyl Fumarate Bgr, Dimethyl Fumarate Biogaran, Dimethyl Fumarate Cipla, Dimethyl Fumarate Eg, Dimethyl Fumarate Olpha, Dimethyl Fumarate Pharmathen, Dimethyl Fumarate Qilu, Dimethyl Fumarate Sandoz, Dimethyl Fumarate Stada, Dimethyl Fumarate Sun, Dimethyl Fumarate Teva, Dimethyl Fumarate Zentiva, Dimethyl Fumarate Zydus, Diméthyl Fumarate Intas, Onavuo, Scefid
Greece
Dimate, Dimethyl Fumarate Aenorasis, Dimethyl Fumarate Ebewe, Dimethyl Fumarate Genepharm, Dimethyl Fumarate Pharmathen, Dimethyl Fumarate Sandoz, Dimethyl Fumarate Teva, Dimethyl Fumarate/Hemopharm, Dimethyl Fumarate/Stada, Dimforda, Dimtruzic, Lafadera, Scleryda
Hungary
Adifemu, Arbicen, Balfumon, Cohiber, Dimethyl Fumarate, Dimetil-Fumarát, Dimforda, Jaxteran
Iceland
Dimethyl Fumarate, Ditagfenda, Dremtis, Endifera, Femsira, Fosclera, Jaxteran, Scefid, Skilarence, Tecfidera, Tigitrax
Ireland
Dimethyl Fumarate
Italy
Berbira, Dimetilfumarato, Dimforda, Dimtruzic, Dremtis, Mustef, Onavuo, Scleryda
Latvia
Cohiber, Dimethyl Fumarate, Dimforda, Dimtelzo, Dimtruzic, Femsira, Fosclera
Liechtenstein
Dimethyl Fumarate Accord, Dimethyl Fumarate Mylan, Dimethyl Fumarate Neuraxpharm, Skilarence, Tecfidera
Lithuania
Arbicen, Cohiber, Dimethyl Fumarate, Dimforda, Dimtelzo, Dimtruzic, Femsira, Fosclera
Luxembourg
Dimethyl Fumarate Eurogenerics
Malta
Dimethyl Fumarate Clonmel, Dimethyl Fumarate Msn, Dimethyl Fumarate Sandoz, Dimethyl Fumarate Torrent, Dimtruzic, Femsira, Scleryda
Netherlands
Dimethyl Fumarate Aurobindo, Dimethylfumaraat Abdi, Dimethylfumaraat Aurobindo, Dimethylfumaraat Biocon, Dimethylfumaraat Cf, Dimethylfumaraat Glenmark, Dimethylfumaraat Macleods, Dimethylfumaraat Msn, Dimethylfumaraat Pharmathen, Dimethylfumaraat Reddy, Dimethylfumaraat Sandoz, Dimethylfumaraat Sdz, Dimethylfumaraat Teva, Dimethylfumaraat Vivanta, Dimethylfumaraat Xiromed, Dimethylfumaraat Zentiva, Ditagfenda, Scleryda
Norway
Dimethyl Fumarate, Dimforda, Skilarence, Tecfidera
Poland
Adifemu, Balfumon, Dimethyl Fumarate, Dimethylis Fumaras Qilu, Dimforda, Dimtelzo, Dimtruzic, Fumaran Dimetylu Adamed, Fumatyl, Jaxteran, Noroplex
Portugal
Fumarato De Dimetilo Aurobindo, Fumarato De Dimetilo Farmoz, Fumarato De Dimetilo Generis, Fumarato De Dimetilo Glenmark, Fumarato De Dimetilo Kern Pharma, Fumarato De Dimetilo Ratiopharm, Fumarato De Dimetilo Reddy, Fumarato De Dimetilo Stada, Fumarato De Dimetilo Stadafarma, Fumarato De Dimetilo Tecnigen, Fumarato De Dimetilo Teva, Fumarato De Dimetilo Vivanta, Fumarato De Dimetilo Zentiva, Fumarato De Dimetilo Zim
Romania
Dimethyl Fumarate, Dimetil Fumarat, Dimtelzo, Dimtruzic, Jaxteran, Zeimem
Slovakia
Adifemu, Arbicen, Cohiber, Dimethyl Fumarate Gedeon Richter, Dimethyl Fumarate Glenmark, Dimethyl Fumarate Msn, Dimethyl Fumarate Olpha, Dimethyl Fumarate Stada Arzneimittel, Dimethyl Fumarate Teva Gmbh, Dimethyl Fumarate Teva Slovakia, Dimetyl-Fumarát G.L. Pharma, Dimetyl-Fumarát Sandoz, Dimetyl-Fumarát Stada, Dimforda, Dimtelzo, Dimtruzic, Jaxteran, Nideolo, Tigitrax
Slovenia
Dimethyl Fumarate Msn, Dimetilfumarat Sandoz, Dimetilfumarat Stada Arzneimittel, Dimetilfumarat Teva Gmbh, Dimforda, Dimtelzo
Spain
Dimforda, Fumarato De Dimetilo Aurovitas, Fumarato De Dimetilo Cipla, Fumarato De Dimetilo Dr. Reddys, Fumarato De Dimetilo Glenmark, Fumarato De Dimetilo Kern Pharma, Fumarato De Dimetilo Liconsa, Fumarato De Dimetilo Macleods, Fumarato De Dimetilo Olpha, Fumarato De Dimetilo Pharmathen, Fumarato De Dimetilo Qilu, Fumarato De Dimetilo Sandoz Farmacéutica, Fumarato De Dimetilo Stadafarma, Fumarato De Dimetilo Sun, Fumarato De Dimetilo Tecnigen, Fumarato De Dimetilo Tevagen, Fumarato De Dimetilo Vivanta, Onavuo
Sweden
Dimethyl Fumarate, Dimetylfumarat Avansor, Dimforda, Zeimem

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Skilarence – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/skilarence-epar-product-information_en.pdf
  2. European Medicines Agency. Tecfidera – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/tecfidera-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  6. Wikidata (CC0): ATC L04AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.