This is a summary of the European public assessment report (EPAR) for Trajenta. 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 Trajenta.
Trajenta : EPAR - Summary for the public (PDF/76.28 KB)
First published: 06/10/2011
Last updated: 15/04/2013
Trajenta : EPAR - Risk Management Plan (PDF/1.87 MB)
First published: 10/12/2019
Last updated: 17/05/2023
|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
30/03/2023 Trajenta - EMEA/H/C/002110 - II/0049
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).
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
Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
as combination therapy
- in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
- in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
- in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.