Trajenta

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linagliptin

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 12/07/2018

Authorisation details

Product details
Name
Trajenta
Agency product number
EMEA/H/C/002110
Active substance
linagliptin
International non-proprietary name (INN) or common name
linagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH05
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
23/08/2011
Contact address
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Product information

25/06/2018 Trajenta - EMEA/H/C/002110 - N/0032

Contents

  • 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.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:

as monotherapy

  • 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.

Assessment history

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