Entyvio
vedolizumab
Table of contents
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.
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List item
Entyvio : EPAR - Summary for the public (PDF/129.21 KB)
First published: 16/06/2014
Last updated: 18/05/2020
EMA/178684/2020 -
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Entyvio : EPAR - Risk-management-plan summary (PDF/169.77 KB)
First published: 16/06/2014
Last updated: 18/05/2020
EMA/174665/2014
Authorisation details
Product details | |
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Name |
Entyvio
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Agency product number |
EMEA/H/C/002782
|
Active substance |
vedolizumab
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International non-proprietary name (INN) or common name |
vedolizumab
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
L04AA
|
Publication details | |
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Marketing-authorisation holder |
Takeda Pharma A/S
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Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
22/05/2014
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Contact address |
Delta Park 45 |
Product information
05/11/2020 Entyvio - EMEA/H/C/002782 - IAIN/0055
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
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.