🇪🇺 SPM 962 in European Union

EMA authorised SPM 962 on 16 June 2011

Marketing authorisations

EMA — authorised 16 June 2011

  • Application: EMEA/H/C/002380
  • Marketing authorisation holder: UCB Pharma S.A.
  • Local brand name: Leganto
  • Indication: Leganto is indicated for the symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in adults. Leganto is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).
  • Status: withdrawn

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EMA — authorised 26 January 2018

  • Application: EMEA/H/C/004286
  • Marketing authorisation holder: Mylan S.A.S
  • Local brand name: Rotigotine Mylan
  • Indication: Treatment of idiopathic Restless Legs Syndrome and Parkinson's disease.
  • Status: withdrawn

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Frequently asked questions

Is SPM 962 approved in European Union?

Yes. EMA authorised it on 16 June 2011; EMA authorised it on 26 January 2018.

Who is the marketing authorisation holder for SPM 962 in European Union?

UCB Pharma S.A. holds the EU marketing authorisation.