Entyvio

RSS

vedolizumab

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

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.

This EPAR was last updated on 29/03/2022

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
21
Date of issue of marketing authorisation valid throughout the European Union
22/05/2014
Contact address

Delta Park 45
2665 Vallensbaek Strand 
Denmark

Product information

28/03/2022 Entyvio - EMEA/H/C/002782 - IA/0069

Product information documents contain:

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

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.

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.

Assessment history

Changes since initial authorisation of medicine

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