Truberzi

eluxadoline

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Truberzi has been withdrawn at the request of the marketing-authorisation holder.

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
- Bulgarian
  (PDF/658.78 KB)
- Croatian
  (PDF/649.91 KB)
- Czech
  (PDF/657.3 KB)
- Danish
  (PDF/631.54 KB)
- Dutch
  (PDF/631.78 KB)
- Estonian
  (PDF/629.29 KB)
- Finnish
  (PDF/629.39 KB)
- French
  (PDF/632.93 KB)
- German
  (PDF/632.88 KB)
- Greek
  (PDF/660.58 KB)
- Hungarian
  (PDF/653.4 KB)
- Italian
  (PDF/631.92 KB)
- Latvian
  (PDF/653.3 KB)
- Lithuanian
  (PDF/657.41 KB)
- Maltese
  (PDF/656.52 KB)
- Polish
  (PDF/658.69 KB)
- Portuguese
  (PDF/632.41 KB)
- Romanian
  (PDF/651.82 KB)
- Slovak
  (PDF/654.11 KB)
- Slovenian
  (PDF/649.22 KB)
- Spanish
  (PDF/632.15 KB)
- Swedish
  (PDF/629.96 KB)
List item

Truberzi : EPAR - Risk-management-plan summary (PDF/733.27 KB)

First published: 26/03/2019
Last updated: 25/02/2021

This EPAR was last updated on 25/02/2021

Authorisation details

Product details
Name	Truberzi
Agency product number	EMEA/H/C/004098
Active substance	Eluxadoline
International non-proprietary name (INN) or common name	eluxadoline
Therapeutic area (MeSH)	Irritable Bowel Syndrome Diarrhea
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
Marketing-authorisation holder	Allergan Pharmaceuticals International Limited
Revision	6
Date of issue of marketing authorisation valid throughout the European Union	19/09/2016
Contact address	Clonshaugh Industrial Estate Coolock Dublin 17 Ireland

Product information

12/02/2020 Truberzi - EMEA/H/C/004098 - IAIN/0013

List item

Truberzi : EPAR - Product Information (PDF/1.63 MB)

First published: 29/09/2016
Last updated: 25/02/2021
- Bulgarian
  (PDF/3 MB)
- Croatian
  (PDF/1.81 MB)
- Czech
  (PDF/2.58 MB)
- Danish
  (PDF/1.61 MB)
- Dutch
  (PDF/1.69 MB)
- Estonian
  (PDF/1.59 MB)
- Finnish
  (PDF/1.6 MB)
- French
  (PDF/1.65 MB)
- German
  (PDF/1.62 MB)
- Greek
  (PDF/3.13 MB)
- Hungarian
  (PDF/2.55 MB)
- Icelandic
  (PDF/1.71 MB)
- Italian
  (PDF/1.68 MB)
- Latvian
  (PDF/2.7 MB)
- Lithuanian
  (PDF/1.86 MB)
- Maltese
  (PDF/2.73 MB)
- Norwegian
  (PDF/1.66 MB)
- Polish
  (PDF/2.67 MB)
- Portuguese
  (PDF/1.74 MB)
- Romanian
  (PDF/386.01 KB)
- Slovak
  (PDF/2.57 MB)
- Slovenian
  (PDF/2.5 MB)
- Spanish
  (PDF/1.58 MB)
- Swedish
  (PDF/1.64 MB)

Other EU languages available icon 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.

List item

Truberzi : EPAR - All Authorised presentations (PDF/575.78 KB)

First published: 29/09/2016
Last updated: 25/02/2021
- Bulgarian
  (PDF/596.62 KB)
- Croatian
  (PDF/582.33 KB)
- Czech
  (PDF/582.17 KB)
- Danish
  (PDF/574.73 KB)
- Dutch
  (PDF/574.36 KB)
- Estonian
  (PDF/574.84 KB)
- Finnish
  (PDF/575.79 KB)
- French
  (PDF/574.52 KB)
- German
  (PDF/574.68 KB)
- Greek
  (PDF/596.72 KB)
- Hungarian
  (PDF/631.34 KB)
- Icelandic
  (PDF/574.37 KB)
- Italian
  (PDF/574.37 KB)
- Latvian
  (PDF/594.07 KB)
- Lithuanian
  (PDF/594.78 KB)
- Maltese
  (PDF/589.69 KB)
- Norwegian
  (PDF/574.34 KB)
- Polish
  (PDF/583.38 KB)
- Portuguese
  (PDF/574.48 KB)
- Romanian
  (PDF/591 KB)
- Slovak
  (PDF/582.54 KB)
- Slovenian
  (PDF/581.28 KB)
- Spanish
  (PDF/576.1 KB)
- Swedish
  (PDF/574.21 KB)

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).

Assessment history

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2016

22/07/2016

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Truberzi

Table of contents

Overview

Truberzi : EPAR - Summary for the public (PDF/632.55 KB)

Truberzi : EPAR - Risk-management-plan summary (PDF/733.27 KB)

Authorisation details

Product information

Truberzi : EPAR - Product Information (PDF/1.63 MB)

Truberzi : EPAR - All Authorised presentations (PDF/575.78 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Truberzi : EPAR - Procedural steps taken and scientific information after authorisation (PDF/730.18 KB)

Truberzi-H-C-PSUSA-00010528-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/688.77 KB)

Initial marketing-authorisation documents

Truberzi : EPAR - Public assessment report (PDF/2.86 MB)

CHMP summary of positive opinion for Truberzi (PDF/635.45 KB)

News

Related content

More information on Truberzi

Public statement on Truberzi: Withdrawal of the marketing authorisation in the European Union (PDF/129.34 KB)

Related content

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