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teriflunomide

Aubagio · ATC code L04AK02

Also known as: Teriflunomid · Brand names: Aubagio, Terebyo, Teriflunomid +pharma, Teriflunomid Devatis, Teriflunomid Genericon, Teriflunomid Glenmark, Teriflunomid Hcs, Teriflunomid Ratiopharm, Teriflunomid Stada, Teriflunomid Zentiva, Teriflunomide G.L., Teriflago, Teriflu Viatris, Theditrax, Avonomide …

Key facts
Active substance
teriflunomide
Drug class
Immunosuppressive drug
ATC code
L04AK02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
AUBAGIO 7 mg film-coated tablets / AUBAGIO 14 mg film-coated tablets
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-28

Key facts

Teriflunomide (Aubagio) is an oral immunomodulator, the main metabolite of leflunomide, used to treat relapsing remitting multiple sclerosis.

What it is used for

  • Relapsing remitting multiple sclerosis (MS) in adults and paediatric patients aged 10 years and older.

Dosing

  • Adults: 14 mg once daily, with or without food, swallowed whole.
  • Children from 10 years: >40 kg 14 mg once daily; ≤40 kg 7 mg once daily; switch to 14 mg once a stable weight above 40 kg is reached.
  • No dose adjustment in mild to severe renal impairment without dialysis or in mild and moderate hepatic impairment; use with caution from 65 years.

Contraindications

  • Hypersensitivity to the active substance or any excipient; severe hepatic impairment (Child-Pugh C).
  • Pregnancy, and women of childbearing potential not using reliable contraception while plasma levels are above 0.02 mg/l; breast-feeding.
  • Severe immunodeficiency (e.g. AIDS), significantly impaired bone marrow function or significant cytopenias; severe active infection until resolved.
  • Severe renal impairment on dialysis; severe hypoproteinaemia (e.g. nephrotic syndrome).

Important warnings

  • Before starting, check blood pressure, ALT and full blood count; liver enzymes at least every four weeks for the first 6 months, then regularly; weekly if ALT is 2- to 3-fold the upper limit of normal.
  • Teriflunomide stays in the body for a long time; an accelerated elimination procedure (e.g. with cholestyramine or activated charcoal) is available (see the full text).
  • Interstitial lung disease and pulmonary hypertension, which may be fatal, have been reported.
  • Peripheral neuropathy: if confirmed, consider stopping and accelerated elimination.
  • Avoid live attenuated vaccines; consider infection risk.

Side effects

  • Most frequent (7 mg and 14 mg): headache (17.8%, 15.7%), diarrhoea (13.1%, 13.6%), increased ALT (13%, 15%), nausea (8%, 10.7%) and alopecia (9.8%, 13.5%); mostly mild to moderate and transient.

Interactions

  • Potent CYP and transporter inducers (rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort) reduce exposure by approximately 40% – use with caution.
  • Rosuvastatin exposure is markedly increased – reduce the rosuvastatin dose by 50%; caution with other BCRP and OATP substrates (e.g. methotrexate, other statins).
  • Cholestyramine and activated charcoal rapidly lower teriflunomide levels.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy (may cause serious birth defects); exclude pregnancy before starting.
  • The risk of male-mediated embryo-foetal toxicity is considered low.

Summary of the official product information, written with AI on 2026-10-29. 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

This product has no separate US patient information.

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

  • TerebyoSandoz Gmbh · 1 register entry
  • Teriflunomid +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Teriflunomid DevatisDevatis Gmbh · 1 register entry
  • Teriflunomid GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Teriflunomid GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
  • Teriflunomid HcsHcs Bvba · 1 register entry
  • Teriflunomid RatiopharmTeva B.V · 1 register entry
  • Teriflunomid StadaStada Arzneimittel Gmbh · 2 register entries
  • Teriflunomid ZentivaZentiva, K.S. · 1 register entry
  • Teriflunomide G.L.G.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • TerebyoHexal Ag · 1 register entry
  • TeriflagoTad Pharma Gmbh · 1 register entry
  • Teriflu ViatrisViatris Germany Gmbh · 1 register entry
  • Teriflunomid1 A Pharma Gmbh, Betapharm Arzneimittel Gmbh, Hexal Ag, 123 Acurae Pharma Gmbh, Vivanta Generics S.R.O., G.L. Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Ratiopharm Gmbh, Puren Pharma Gmbh & Co. Kg, Glenmark Arzneimittel Gmbh, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Zentiva Pharma Gmbh, Amarox Pharma Gmbh, Elpen Pharmaceutical Co. Inc., Olpha As, Stadapharm Gmbh, Abdi Farma Gmbh, Axunio Pharma Gmbh, Aliud Pharma Gmbh · 22 register entries
  • TheditraxPharmathen S.A. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AubagioSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 1 register entry
  • AvonomideTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • AvoranSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BaudaABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • FlunigenGENVEON İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • FlunotuONKO İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • RepisodeFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • TeflimesTEVA PHARMA İLAÇ SAN.VE TİC. A.Ş. · 1 register entry
  • TerigioSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • TheiramidİLKO İLAÇ SAN.VE TİC. A.Ş. · 1 register entry

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

Brand names in 28 more European countries
Belgium
Terebyo, Teriflunomid Eurogenerics, Teriflunomide Eg, Teriflunomide Eurogenerics, Teriflunomide Krka
Bulgaria
Terebyo, Teriflunomide Msn, Арегалу, Боксарид, Клефирем, Терифлуномид Деватис, Терифлуномид Зентива, Терифлуномид Фармасайънс
Croatia
Aregalu, Telirem, Telunis, Tergio, Teriflunomid, Tifay
Cyprus
Aregalu, Arogio, Feple, Telirem, Tergio, Teriflunomide Msn, Teriflunomide Sapiens, Teriflunomide Stada, Teriflunomide Teva
Czechia
Aregalu, Boxarid, Bozilos, Clefirem, Terebyo, Teriflunomid +pharma, Teriflunomid Abdi, Teriflunomid Zentiva, Teriflunomide Auxpharma, Teriflunomide G.L. Pharma, Teriflunomide Glenmark, Teriflunomide Msn, Teriflunomide Neuraxpharrn, Teriflunomide Pharmathen, Teriflunomide Teva, Teriflunomide Vipharm, Tifay
Denmark
Clefirem, Teriflunomid Devatis, Teriflunomid Pharmathen, Teriflunomid Stada, Teriflunomid Zentiva, Teriflunomide, Theditrax Pharmathen
Estonia
Aregalu, Boxarid, Telirem, Tenamid, Terebyo, Teriflunomide Glenmark, Teriflunomide Teva, Teriflunomide Tevapharm, Teriflunomide Zentiva, Tifay
Finland
Clefirem, Teriflunomide Avansor, Teriflunomide Devatis, Teriflunomide Glenmark, Teriflunomide Krka, Teriflunomide Olpha, Teriflunomide Orion, Teriflunomide Ratiopharm, Teriflunomide Sandoz, Teriflunomide Stada
France
Terebyo, Teriflunomide Arrow, Teriflunomide Biogaran, Teriflunomide Cristers, Teriflunomide Eg, Teriflunomide Evolugen, Teriflunomide Hcs, Teriflunomide Neuraxpharm, Teriflunomide Olpha, Teriflunomide Teva, Teriflunomide Viatris Sante, Teriflunomide Zentiva, Teriflunomide Zydus
Greece
Aregalu, Arogio, Feple, Terebyo, Tergio, Teriflunomide Genepharm, Teriflunomide Stada, Teriflunomide Teva, Teriflunomide Winmedica, Theditrax
Hungary
Aregalu, Arogio, Boxarid, Bozilos, Clefirem, Teriflunomid Galenika, Teriflunomid Onkogen, Teriflunomide
Iceland
Aubagio, Feple, Tergio, Teriflunomid, Teriflunomide Accord, Teriflunomide Krka, Teriflunomide Medical Valley, Teriflunomide Neuraxpharm, Teriflunomide Sandoz, Teriflunomide Stada, Teriflunomide Teva, Teriflunomide Viatris, Tifay
Ireland
Teriflunomide Clonmel
Italy
Clefirem, Terebyo, Tergio, Teriflunomide Abdi, Teriflunomide Aurobindo, Teriflunomide Dr. Reddys, Teriflunomide Eg, Teriflunomide Glenmark, Teriflunomide Hcs, Teriflunomide Teva Italia, Teriflunomide Viatris Pharma, Teriflunomide Zentiva
Latvia
Aregalu, Boxarid, Clefirem, Terebyo, Teriflunomide Glenmark, Teriflunomide Lv System Service Sia, Teriflunomide Olpha, Teriflunomide Stada, Teriflunomide Tevapharm, Teriflunomide Zentiva, Tifay
Liechtenstein
Aubagio, Teriflunomide Accord, Teriflunomide Viatris
Lithuania
Aregalu, Boxarid, Clefirem, Tenamid, Terebyo, Teriflunomide Glenmark, Teriflunomide Olpha, Teriflunomide Stada, Teriflunomide Zentiva, Tifay
Luxembourg
Teriflunomide Eg, Teriflunomide Eurogenerics
Malta
Telirem, Tergio, Teriflunomide
Netherlands
Teriflox, Teriflunomide Abdi, Teriflunomide Amarox, Teriflunomide Aurobindo, Teriflunomide Centrafarm, Teriflunomide Cf, Teriflunomide Devatis, Teriflunomide Glenmark, Teriflunomide Sandoz, Teriflunomide Teva, Teriflunomide Vivanta
Norway
Aubagio, Clefirem, Teriflunomid Devatis, Teriflunomid Neuraxpharm, Teriflunomid Zentiva, Teriflunomide
Poland
Aregalu, Boxarid, Bozilos, Clefirem, Terebyo, Teriflunomid Adamed, Teriflunomide +pharma, Teriflunomide Aurovitas, Teriflunomide G.L. Pharma, Teriflunomide Glenmark, Teriflunomide Medical Valley, Teriflunomide Msn, Teriflunomide Neuraxpharm, Teriflunomide Pharmathen, Teriflunomide Ranbaxy, Teriflunomide Vipharm, Teriflunomide Zentiva, Tifay
Portugal
Teriflunomida Basi, Teriflunomida Bluepharma, Teriflunomida Generis, Teriflunomida Glenmark, Teriflunomida Krka, Teriflunomida Pharmakern, Teriflunomida Ratiopharm, Teriflunomida Sandoz, Teriflunomida Stada, Teriflunomida Viatris, Teriflunomida Zentiva, Teriflunomide Liconsa
Romania
Boxarid, Bozilos, Feple, Terebyo, Teriflunomidă Dr. Reddy’s, Teriflunomidă Msn, Teriflunomidă Stada, Teriflunomidă Terapia, Teriflunomidă Teva, Teriflunomidă Zentiva
Slovakia
Aregalu, Boxarid, Bozilos, Clefirem, Terebyo, Teriflago, Teriflunomid Galenika, Teriflunomid Krka, Teriflunomid Teva, Teriflunomide G.L. Pharma, Teriflunomide Glenmark, Teriflunomide Hcs, Teriflunomide Msn, Teriflunomide Neuraxpharm, Teriflunomide Pharmathen, Teriflunomide Stada, Teriflunomide Vipharm, Teriflunomide Zentiva
Slovenia
Aregalu, Clefirem, Terebyo, Teriflunomid Galenika, Teriflunomid Msn
Spain
Clefirem, Teriflunomida Aurovitas, Teriflunomida Dr. Reddys, Teriflunomida Efg Stadafarma, Teriflunomida Glenmark, Teriflunomida Kern Pharma, Teriflunomida Krka, Teriflunomida Neuraxpharm, Teriflunomida Sandoz, Teriflunomida Stada, Teriflunomida Stadafarma, Teriflunomida Tarbis, Teriflunomida Tevagen, Teriflunomida Viatris Pharmaceuticals, Teriflunomida Vivanta, Teriflunomida Zentiva, Theditrax
Sweden
Clefirem, Teriflunomid Devatis, Teriflunomid Sun, Teriflunomid Zentiva, Teriflunomide

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. European Medicines Agency. Aubagio – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/aubagio-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC L04AK.

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.