This is a summary of the European public assessment report (EPAR) for Alofisel. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Alofisel.
For practical information about using Alofisel, patients should read the package leaflet or contact their doctor or pharmacist.
Alofisel : EPAR - Summary for the public (PDF/76.87 KB)
First published: 04/04/2018
Last updated: 04/04/2018
Alofisel : EPAR - Risk-management-plan summary (PDF/75.62 KB)
First published: 29/07/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Takeda Pharma A/S
|Date of issue of marketing authorisation valid throughout the European Union||
Delta Park 45
10/01/2023 Alofisel - EMEA/H/C/004258 - R/0036
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.