🇪🇺 Azilect® in European Union

EMA authorised Azilect® on 12 January 2015

Marketing authorisations

EMA — authorised 12 January 2015

  • Application: EMEA/H/C/003957
  • Marketing authorisation holder: Teva B.V.
  • Local brand name: Rasagiline ratiopharm
  • Indication: Rasagiline ratiopharm is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
  • Status: approved

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EMA — authorised 4 April 2016

  • Application: EMEA/H/C/004064
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Rasagiline Viatris (previously Rasagiline Mylan)
  • Indication: Rasagiline Viatris is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
  • Status: approved

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Azilect® in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Azilect® approved in European Union?

Yes. EMA authorised it on 12 January 2015; EMA authorised it on 4 April 2016.

Who is the marketing authorisation holder for Azilect® in European Union?

Teva B.V. holds the EU marketing authorisation.