🇪🇺 Safinamide Methanesulfonate in European Union

EMA authorised Safinamide Methanesulfonate on 23 February 2015

Marketing authorisation

EMA — authorised 23 February 2015

  • Application: EMEA/H/C/002396
  • Marketing authorisation holder: Zambon SpA
  • Local brand name: Xadago
  • Indication: Xadago is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
  • Status: approved

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Other Neurology approved in European Union

Frequently asked questions

Is Safinamide Methanesulfonate approved in European Union?

Yes. EMA authorised it on 23 February 2015.

Who is the marketing authorisation holder for Safinamide Methanesulfonate in European Union?

Zambon SpA holds the EU marketing authorisation.