Overview

The marketing authorisation for Truberzi has been withdrawn at the request of the marketing-authorisation holder. 

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Product information

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Latest procedure affecting product information: IAIN/0013

12/02/2020

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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).

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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

Topics

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