Truberzi
Withdrawn
This medicine's authorisation has been withdrawn
eluxadoline
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The European Public Assessment Report (EPAR) for Truberzi is updated to indicate that the marketing authorisation is no longer valid.
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).
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 agentsTherapeutic indication
Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).
News on Truberzi
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