Alofisel | European Medicines Agency (EMA)

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Overview

On 13 December 2024, the European Commission withdrew the marketing authorisation for Alofisel (darvadstrocel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Takeda Pharma A/S, which notified the European Commission of its decision to permanently stop the marketing of the product in the EU.

Alofisel was granted marketing authorisation in the EU on 23 March 2018 for the treatment of complex perianal fistulas. The European Public Assessment Report (EPAR) for Alofisel is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information:
II/0044/G

14/09/2023

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This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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latviešu valoda (LV)
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slovenčina (SK)
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Product details

Name of medicine

Alofisel

Active substance

darvadstrocel

International non-proprietary name (INN) or common name

darvadstrocel

Therapeutic area (MeSH)

Rectal Fistula

Anatomical therapeutic chemical (ATC) code

L04

Pharmacotherapeutic group

Immunosuppressants

Therapeutic 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.

More information on Alofisel

This product was originally designated an orphan medicine on 8 October 2009. Alofisel was withdrawn from the Community register of orphan medicinal products by the European Commission in December 2024 at the time of the withdrawal of the marketing authorisation.

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