🇪🇺 Gilenya in European Union

EMA authorised Gilenya on 17 March 2011

Marketing authorisation

EMA — authorised 17 March 2011

  • Application: EMEA/H/C/002202
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Gilenya
  • Indication: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on
  • Status: approved

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Gilenya in other countries

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

Other Neuroscience approved in European Union

Frequently asked questions

Is Gilenya approved in European Union?

Yes. EMA authorised it on 17 March 2011.

Who is the marketing authorisation holder for Gilenya in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.