Truberzi

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eluxadoline

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Truberzi has been withdrawn at the request of the marketing-authorisation holder. 

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 monitoringAdditional 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

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

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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