Truberzi

RSS

eluxadoline

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

Overview

This is a summary of the European public assessment report (EPAR) for Truberzi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Truberzi.

For practical information about using Truberzi, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 25/10/2018

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
4
Date of issue of marketing authorisation valid throughout the European Union
18/09/2016
Contact address
Clonshaugh Industrial Estate
Coolock
Dublin 17
Ireland

Product information

05/09/2018 Truberzi - EMEA/H/C/004098 - II/0005/G

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

  • 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

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