MedeliX
Start asking

riluzole

Rilutek, Riluzole Zentiva · ATC code N07XX02

Also known as: Riluzol · Brand names: Rilutek, Riluzole Zentiva, Emylif, Riluzol Aristo, Riluzol Pmcs, Riluzol Stada, Glentek, Teglutik

Key facts
Active substance
riluzole
ATC code
N07XX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
RILUTEK 50 mg film-coated tablets · Riluzole Zentiva 50 mg film-coated tablets
Marketing authorisation holder
Sanofi Winthrop Industrie, Zentiva k.s.
Information as of
2026-10-27

Key facts

Riluzole is a glutamate antagonist. It is used in amyotrophic lateral sclerosis (ALS) to extend life or the time to mechanical ventilation.

What it is used for

  • Amyotrophic lateral sclerosis (ALS): to extend survival or time to mechanical ventilation
  • No evidence of effect on motor function, lung function or muscle strength; not effective in late stages
  • Not for other forms of motor neurone disease

Dosing

  • Adults and older people: 100 mg daily (50 mg every 12 hours)
  • No significant added benefit from higher daily doses
  • Not recommended in impaired renal function or in children
  • Initiated only by specialists experienced in motor neurone disease

Contraindications

  • Hypersensitivity to the active substance or any of the excipients
  • Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal
  • Pregnancy and breast-feeding

Important warnings

  • Risk of hepatitis: ALT monthly for the first 3 months, every 3 months for the rest of year one, then periodically
  • Discontinue if ALT rises to 5 times the ULN
  • Neutropenia: report febrile illness; check white blood cell counts
  • Interstitial lung disease

Side effects

  • Most common: asthenia, nausea, abnormal liver function tests
  • Headache, dizziness, oral paraesthesia, somnolence, tachycardia
  • Diarrhoea, abdominal pain, vomiting
  • Serious: severe neutropenia, interstitial lung disease, pancreatitis, hepatitis, angioedema

Interactions

  • Mainly metabolised by CYP1A2
  • CYP1A2 inhibitors (e.g., caffeine, diclofenac, fluvoxamine, theophylline, quinolones) could decrease elimination
  • CYP1A2 inducers (e.g., cigarette smoke, rifampicin, omeprazole) could increase elimination

Pregnancy and breastfeeding

  • Contraindicated in pregnancy and breast-feeding

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

  • EmylifZambon S.P.A. · 1 register entry
  • Riluzol AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Riluzol PmcsPro.Med.Cs Praha A.S. · 1 register entry
  • Riluzol StadaStada Arzneimittel Gmbh · 1 register entry

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

Germany

  • EmylifZambon S.P.A. · 1 register entry
  • GlentekGlenmark Arzneimittel Gmbh · 1 register entry
  • Riluzol1 A Pharma Gmbh, Neuraxpharm Arzneimittel Gmbh, Ratiopharm Gmbh, Hormosan Pharma Gmbh, Ascend Gmbh, Hexal Ag, Betapharm Arzneimittel Gmbh, Sun Pharmaceuticals Germany Gmbh · 8 register entries
  • TeglutikItalfarmaco S.A. · 1 register entry

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

Turkey

  • RilutekSANOFİ SAĞLIK ÜRÜNLERİ LTD. ŞTİ. · 1 register entry
  • TeglutikITF İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

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

Brand names in 23 more European countries
Belgium
Emylif, Riluzol Ab, Teglutik
Croatia
Alsemol
Cyprus
Teglutik
Czechia
Riluzol Pmcs
Denmark
Emylif, Glentek, Riluzol Pmcs
Estonia
Lizolorol, Rilustad, Riluzole Stada, Riluzole Teva, Sclefic
Finland
Teglutik
France
Emylif, Riluzole Arrow, Riluzole Biogaran, Riluzole Eg, Riluzole Sandoz, Riluzole Teva, Riluzole Viatris, Teglutik
Greece
Teglutik
Hungary
Sclefic
Iceland
Emylif, Rilutek, Riluzol Actavis
Italy
Emylif, Riluzolo Aurobindo, Riluzolo Sandoz, Riluzolo Sun, Teglutik
Liechtenstein
Rilutek
Luxembourg
Emylif, Teglutik
Netherlands
Emylif, Glentek, Riluzol, Teglutik
Norway
Emylif, Rilutek, Riluzol Actavis, Teglutik
Poland
Riluzol Pmcs, Riluzole Sun
Portugal
Emylif, Riluzol Aurovitas, Riluzol Kabi, Teglutik
Romania
Riluzol Pmcs
Slovakia
Riluzol Pmcs
Slovenia
Sclefic
Spain
Emylif, Riluzol Aurovitas, Riluzol Pmcs, Riluzol Sun, Teglutik
Sweden
Emylif, Glentek, Riluzol Actavis, Riluzol Pmcs, Riluzol Stada, Teglutik

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

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Rilutek – EPAR, Product Information (OF THE TEXT). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/rilutek-epar-product-information_en.pdf
  2. European Medicines Agency. Riluzole Zentiva – 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/riluzole-zentiva-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

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.