🇪🇺 Vedolizumab IV in European Union

EMA authorised Vedolizumab IV on 22 May 2014

Marketing authorisation

EMA — authorised 22 May 2014

  • Application: EMEA/H/C/002782
  • Marketing authorisation holder: Takeda Pharma A/S
  • Local brand name: Entyvio
  • Indication: Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is
  • Status: approved

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Frequently asked questions

Is Vedolizumab IV approved in European Union?

Yes. EMA authorised it on 22 May 2014.

Who is the marketing authorisation holder for Vedolizumab IV in European Union?

Takeda Pharma A/S holds the EU marketing authorisation.