Truberzi
Withdrawn
This medicine's authorisation has been withdrawn
eluxadoline
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The marketing authorisation for Truberzi has been withdrawn at the request of the marketing-authorisation holder.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
English (EN) (632.55 KB - PDF)
First published: Last updated:
български (BG) (658.78 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
español (ES) (632.15 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
čeština (CS) (657.3 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
dansk (DA) (631.54 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Deutsch (DE) (632.88 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
eesti keel (ET) (629.29 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
ελληνικά (EL) (660.58 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
français (FR) (632.93 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
hrvatski (HR) (649.91 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
italiano (IT) (631.92 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
latviešu valoda (LV) (653.3 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
lietuvių kalba (LT) (657.41 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
magyar (HU) (653.4 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Malti (MT) (656.52 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Nederlands (NL) (631.78 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
polski (PL) (658.69 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
português (PT) (632.41 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
română (RO) (651.82 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
slovenčina (SK) (654.11 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
slovenščina (SL) (649.22 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Suomi (FI) (629.39 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
svenska (SV) (629.96 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Truberzi : EPAR - Risk-management-plan summary
English (EN) (733.27 KB - PDF)
First published: Last updated:
Product information
Truberzi : EPAR - Product Information
English (EN) (1.63 MB - PDF)
First published: Last updated:
български (BG) (3 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
español (ES) (1.58 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
čeština (CS) (2.58 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
dansk (DA) (1.61 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Deutsch (DE) (1.62 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
eesti keel (ET) (1.59 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
ελληνικά (EL) (3.13 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
français (FR) (1.65 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
hrvatski (HR) (1.81 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
íslenska (IS) (1.71 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
italiano (IT) (1.68 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
latviešu valoda (LV) (2.7 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
lietuvių kalba (LT) (1.86 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
magyar (HU) (2.55 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Malti (MT) (2.73 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Nederlands (NL) (1.69 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
norsk (NO) (1.66 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
polski (PL) (2.67 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
português (PT) (1.74 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
română (RO) (386.01 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
slovenčina (SK) (2.57 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
slovenščina (SL) (2.5 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Suomi (FI) (1.6 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
svenska (SV) (1.64 MB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
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
English (EN) (575.78 KB - PDF)
First published: Last updated:
български (BG) (596.62 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
español (ES) (576.1 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
čeština (CS) (582.17 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
dansk (DA) (574.73 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Deutsch (DE) (574.68 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
eesti keel (ET) (574.84 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
ελληνικά (EL) (596.72 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
français (FR) (574.52 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
hrvatski (HR) (582.33 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
íslenska (IS) (574.37 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
italiano (IT) (574.37 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
latviešu valoda (LV) (594.07 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
lietuvių kalba (LT) (594.78 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
magyar (HU) (631.34 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Malti (MT) (589.69 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Nederlands (NL) (574.36 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
norsk (NO) (574.34 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
polski (PL) (583.38 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
português (PT) (574.48 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
română (RO) (591 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
slovenčina (SK) (582.54 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
slovenščina (SL) (581.28 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
Suomi (FI) (575.79 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
svenska (SV) (574.21 KB - PDF)
First published: 29/09/2016Last updated: 25/02/2021
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).
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
Truberzi : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (730.18 KB - PDF)
First published: Last updated:
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
English (EN) (688.77 KB - PDF)
First published: Last updated:
Truberzi : EPAR - Public assessment report
AdoptedReference Number: EMA/549473/2016
English (EN) (2.86 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Truberzi
AdoptedReference Number: EMA/CHMP/467320/2016
English (EN) (635.45 KB - PDF)
First published: Last updated:
News on Truberzi
Related content
- Clinical data (initial marketing authorisation)
More information on Truberzi
Public statement on Truberzi: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/670383/2020
English (EN) (129.34 KB - PDF)
First published:
More information on Truberzi
Topics
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