Entyvio is a medicine 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). Entyvio is used to treat moderately to severely active disease when conventional therapy or medicines called TNF-alfa antagonists are ineffective, no longer effective, or cannot be tolerated by the patient.
Entyvio is also used for the treatment of adult patients with ongoing (chronic) pouchitis (a disease causing inflammation of a pouch created during certain types of surgery where the large intestine in people with ulcerative colitis is removed). Entyvio is used to treat moderately to severely active disease when antibiotic therapy is ineffective or no longer effective.
Entyvio contains the active substance vedolizumab.
Entyvio : EPAR - Summary for the public (PDF/129.94 KB) (updated)
First published: 16/06/2014
Last updated: 09/11/2023
Entyvio : EPAR - Risk-management-plan summary (PDF/106.57 KB)
First published: 16/06/2014
Last updated: 14/09/2023
|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
06/07/2023 Entyvio - EMEA/H/C/002782 - II/0073
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- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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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.
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.
Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 202117/12/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 202028/02/2020
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 201410/07/2014
European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease21/03/2014