Truberzi
eluxadoline
Table of contents
Overview
The marketing authorisation for Truberzi has been withdrawn at the request of the marketing-authorisation holder.
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List item
Truberzi : EPAR - Summary for the public (PDF/632.55 KB)
First published: 29/09/2016
Last updated: 25/02/2021
EMA/CHMP/517539/2016 -
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List item
Truberzi : EPAR - Risk-management-plan summary (PDF/733.27 KB)
First published: 26/03/2019
Last updated: 25/02/2021
Authorisation details
Product details | |
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Name |
Truberzi
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Agency product number |
EMEA/H/C/004098
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Active substance |
Eluxadoline
|
International non-proprietary name (INN) or common name |
eluxadoline
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
A07
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Allergan Pharmaceuticals International Limited
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Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
19/09/2016
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Contact address |
Clonshaugh Industrial Estate
Coolock Dublin 17 Ireland |
Product information
12/02/2020 Truberzi - EMEA/H/C/004098 - IAIN/0013
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
Antidiarrheals, intestinal antiinflammatory / antiinfective agents
Therapeutic indication
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).