Entyvio
vedolizumab
Table of contents
Overview
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.
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List item
Entyvio : EPAR - Summary for the public (PDF/131.4 KB)
First published: 16/06/2014
Last updated: 01/03/2022
EMA/3386/2022 -
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List item
Entyvio : EPAR - Risk-management-plan summary (PDF/67.66 KB)
First published: 16/06/2014
Last updated: 01/03/2022
EMA/174665/2014
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) |
|
Anatomical therapeutic chemical (ATC) code |
L04AA
|
Publication details | |
---|---|
Marketing-authorisation holder |
Takeda Pharma A/S
|
Revision |
24
|
Date of issue of marketing authorisation valid throughout the European Union |
22/05/2014
|
Contact address |
Delta Park 45 |
Product information
24/04/2023 Entyvio - EMEA/H/C/002782 - IB/0076/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
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.
Pouchitis
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.