Alofisel

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darvadstrocel

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 30/05/2018

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
Marketing-authorisation holder
Takeda Pharma A/S
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/03/2018
Contact address
Dybendal Alle 10
2630 Taastrup
Denmark

Product information

08/05/2018 Alofisel - EMEA/H/C/004258 - T/0001

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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