🇪🇺 TYRUKO in European Union

EMA authorised TYRUKO on 22 September 2023

Marketing authorisation

EMA — authorised 22 September 2023

  • Application: EMEA/H/C/005752
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Tyruko
  • Indication: Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2
  • Pathway: biosimilar
  • Status: approved

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TYRUKO in other countries

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

Other Other approved in European Union

Frequently asked questions

Is TYRUKO approved in European Union?

Yes. EMA authorised it on 22 September 2023.

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

Sandoz GmbH holds the EU marketing authorisation.