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 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||
31/10/2019 Trajenta - EMEA/H/C/002110 - WS/1601
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
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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.