🇪🇺 Alofisel in European Union

EMA authorised Alofisel on 23 March 2018

Marketing authorisation

EMA — authorised 23 March 2018

  • Application: EMEA/H/C/004258
  • Marketing authorisation holder: Takeda Pharma A/S
  • Local brand name: Alofisel
  • Indication: Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.
  • Pathway: ATMP
  • Status: withdrawn

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Other Other approved in European Union

Frequently asked questions

Is Alofisel approved in European Union?

Yes. EMA authorised it on 23 March 2018.

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

Takeda Pharma A/S holds the EU marketing authorisation.