Truberzi

Withdrawn

This medicine's authorisation has been withdrawn

eluxadoline

Overview

The marketing authorisation for Truberzi has been withdrawn at the request of the marketing-authorisation holder. 

Truberzi : EPAR - Summary for the public

Reference Number: EMA/CHMP/517539/2016

Truberzi : EPAR - Risk-management-plan summary

Product information

Truberzi : EPAR - Product Information

Latest procedure affecting product information: IAIN/0013

12/02/2020

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).

Truberzi : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Truberzi
• 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

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).

Authorisation details

• EMA product number:
  EMEA/H/C/004098
• Marketing authorisation holder:
  Allergan Pharmaceuticals International Limited

  Clonshaugh Industrial Estate; Coolock; Dublin 17; Ireland

• Opinion adopted:
  21/07/2016
• Marketing authorisation issued:
  19/09/2016
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Truberzi : EPAR - Procedural steps taken and scientific information after authorisation

Truberzi-H-C-PSUSA-00010528-201703 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/833234/2017

Initial marketing authorisation documents

Truberzi : EPAR - Public assessment report

AdoptedReference Number: EMA/549473/2016

CHMP summary of positive opinion for Truberzi

AdoptedReference Number: EMA/CHMP/467320/2016