Entyvio

RSS

vedolizumab

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

Overview

Entyvio is a medicine that contains the active substance vedolizumab. It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the bowel) or Crohn’s disease (a disease causing inflammation of the digestive tract). Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient.

This EPAR was last updated on 12/10/2020

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
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
22/05/2014
Contact address
Dybendal Alle 10
2630 Taastruup
Denmark

Product information

25/09/2020 Entyvio - EMEA/H/C/002782 - IB/0054/G

Contents

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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

Changes since initial authorisation of medicine

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