Alofisel
darvadstrocel
Table of contents
Overview
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.
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List item
Alofisel : EPAR - Summary for the public (PDF/76.87 KB)
First published: 04/04/2018
Last updated: 04/04/2018
EMA/1380/2018 -
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List item
Alofisel : EPAR - Risk-management-plan summary (PDF/75.62 KB)
First published: 29/07/2019
Authorisation details
Product details | |
---|---|
Name |
Alofisel
|
Agency product number |
EMEA/H/C/004258
|
Active substance |
darvadstrocel
|
International non-proprietary name (INN) or common name |
darvadstrocel
|
Therapeutic area (MeSH) |
Rectal Fistula
|
Anatomical therapeutic chemical (ATC) code |
L04
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Takeda Pharma A/S
|
Revision |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
23/03/2018
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Contact address |
Delta Park 45 |
Product information
26/04/2023 Alofisel - EMEA/H/C/004258 - II/0045/G
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).
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.
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.