linagliptin / metformin hydrochloride
This is a summary of the European public assessment report (EPAR) for Jentadueto. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jentadueto.
Jentadueto : EPAR - Summary for the public (PDF/120.52 KB)
First published: 16/08/2012
Last updated: 21/07/2016
Jentadueto : EPAR - Risk-management-plan summary (PDF/104.3 KB)
First published: 10/12/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
Boehringer Ingelheim International GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
Binger Strasse 173
D-55216 Ingelheim am Rhein
04/03/2022 Jentadueto - EMEA/H/C/002279 - IAIN/0064/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Drugs used in diabetes
Treatment of adult patients with type-2 diabetes mellitus:
- Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.
- Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 201320/12/2013
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes26/03/2013