🇪🇺 XOI in European Union

EMA authorised XOI on 15 June 2017

Marketing authorisations

EMA — authorised 15 June 2017

  • Application: EMEA/H/C/004374
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Febuxostat Viatris (previously Febuxostat Mylan)
  • Indication: Febuxostat Viatris is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).   Febuxostat Viatris is indicated in adults.
  • Status: approved

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EMA — authorised 28 March 2019

  • Application: EMEA/H/C/004773
  • Marketing authorisation holder: Krka, d.d., Novo mesto
  • Local brand name: Febuxostat Krka
  • Indication: Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Krka is indicated in adults.
  • Status: approved

Read official source →

XOI in other countries

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

Other Gastroenterology approved in European Union

Frequently asked questions

Is XOI approved in European Union?

Yes. EMA authorised it on 15 June 2017; EMA authorised it on 28 March 2019.

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

Viatris Limited holds the EU marketing authorisation.