Truberzi

Withdrawn

This medicine's authorisation has been withdrawn

eluxadoline

Overview

On 18 December 2020 the European Commission withdrew the marketing authorisation for Truberzi (eluxadoline) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Allergan Pharmaceuticals International Limited, which notified the European Commission of its decision to discontinue the marketing of the product for commercial reasons. 

Truberzi was granted marketing authorisation in the EU on 19 September 2016 for the treatment of irritable bowel syndrome with diarrhoea. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2018. 

The European Public Assessment Report (EPAR) for Truberzi is updated to indicate that the marketing authorisation is no longer valid.

Truberzi : EPAR - Summary for the public

Reference Number: EMA/CHMP/517539/2016

Truberzi : EPAR - Risk-management-plan summary

Product information

Truberzi : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  18/12/2020
• 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

Adopted Reference Number: EMA/549473/2016

CHMP summary of positive opinion for Truberzi

Adopted Reference Number: EMA/CHMP/467320/2016