Entyvio

RSS

vedolizumab

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

Overview

This is a summary of the European public assessment report (EPAR) for Entyvio. 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 Entyvio.

For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 03/09/2018

Authorisation details

Product details
Name
Entyvio
Agency product number
EMEA/H/C/002782
Active substance
vedolizumab
International non-proprietary name (INN) or common name
vedolizumab
Therapeutic area (MeSH)
  • Colitis, Ulcerative
  • Crohn Disease
Anatomical therapeutic chemical (ATC) code
L04AA
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.

Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
21/05/2014
Contact address
Dybendal Alle 10
2630 Taastruup
Denmark

Product information

22/08/2018 Entyvio - EMEA/H/C/002782 - IB/0030

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

Selective immunosuppressants

Therapeutic indication

Ulcerative colitis
Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.

Crohn’s disease
Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNFα) antagonist.

Assessment history

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