🇪🇺 urate oxidase in European Union

EMA authorised urate oxidase on 23 February 2001

Marketing authorisation

EMA — authorised 23 February 2001

  • Application: EMEA/H/C/000331
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Fasturtec
  • Indication: Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
  • Status: approved

Read official source →

Frequently asked questions

Is urate oxidase approved in European Union?

Yes. EMA authorised it on 23 February 2001.

Who is the marketing authorisation holder for urate oxidase in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.