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safinamide

Xadago · ATC code N04B

Also known as: Safinamid · Brand names: Xadago, Safinamid Al, Safinamid Puren, Safinamid Stada, Safinamid Vivanta

Key facts
Active substance
safinamide
Drug class
Dopaminergic
ATC code
N04B
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Xadago 50 mg film-coated tablets / Xadago 100 mg film-coated tablets
Marketing authorisation holder
Zambon SpA
Information as of
2026-10-28

Key facts

Safinamide (Xadago, film-coated tablets) is a MAO-B inhibitor. It is used as add-on therapy to levodopa in Parkinson's disease with motor fluctuations.

What it is used for

  • Adults with idiopathic Parkinson's disease in mid- to late-stage fluctuating patients, as add-on to a stable dose of levodopa alone or with other Parkinson's medicines.

Dosing

  • Start at 50 mg per day; may be increased to 100 mg/day based on clinical need.
  • Missed dose: take the next dose at the usual time the next day.
  • Moderate hepatic impairment: 50 mg/day; stop if impairment progresses to severe.
  • No dose change in elderly patients or renal impairment; take with water, with or without food.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Concomitant treatment with other MAO inhibitors or pethidine.
  • Severe hepatic impairment.
  • Albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy.

Important warnings

  • SSRIs only at the lowest effective dose with caution for serotoninergic symptoms; avoid fluoxetine and fluvoxamine.
  • At least 7 days between stopping safinamide and starting MAO inhibitors or pethidine.
  • Do not give to patients at increased risk of retinal effects.
  • Impulse control disorders (e.g. pathological gambling, hypersexuality, binge eating) can occur.

Side effects

  • Most common: dyskinesia.
  • Also common: insomnia, somnolence, dizziness, headache, cataract, orthostatic hypotension, nausea.
  • Serious reactions with SSRIs, SNRIs, tricyclic/tetracyclic antidepressants or MAO inhibitors: hypertensive crisis, neuroleptic malignant syndrome, serotonin syndrome.

Interactions

  • Other MAO inhibitors (including moclobemide) and pethidine are contraindicated.
  • Caution with sympathomimetics, such as ephedrine or pseudoephedrine in cold medicines.
  • With BCRP substrates refer to that medicine's SmPC; for dextromethorphan see the full text.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Should not be used during breast-feeding.

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 →

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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)

  • XadagoZambon SpA · EMEA/H/C/002396

Source: European Medicines Agency (EMA), product information

Germany

  • Safinamid AlAliud Pharma Gmbh · 1 register entry
  • Safinamid PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Safinamid StadaStadapharm Gmbh, Stada Arzneimittel Ag · 2 register entries
  • Safinamid VivantaVivanta Generics S.R.O · 1 register entry

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

Brand names in 19 more European countries
Belgium
Safinamide Ab, Safinamide Eg
Croatia
Safinamid Msn, Safinamide Msn
Cyprus
Orvago
Denmark
Safinamid Vivanta
Estonia
Safinamide Teva
Finland
Safinamide Vivanta
Greece
Orvago, Safinamide Win Medica
Iceland
Xadago
Italy
Safinamide Aurobindo, Safinamide Doc, Safinamide Eg, Safinamide Teva, Safinamide Tiefenbacher
Latvia
Safinamide Teva
Liechtenstein
Xadago
Lithuania
Safinamide Teva
Luxembourg
Safinamide Eg
Malta
Safinamide Nio
Netherlands
Safinamide Vivanta
Norway
Safinamide Vivanta, Xadago
Portugal
Safinamida Aurobindo, Safinamida Generis
Spain
Safinamida Aurovitas, Safinamida Cinfa, Safinamida Stada, Safinamida Teva, Safinamida Vivanta, Safinamide Vivanta
Sweden
Orvago, Safinamid Doc, Safinamid Elpen, Safinamid Teva, Safinamide Stada, Safinamide Vivanta, Safinamide Win Medica

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

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

Another question about this substance?

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Sources

  1. European Medicines Agency. Xadago – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/xadago-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. Wikidata (CC0): ATC N04B.

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.