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 17/05/2023

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
19
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

30/03/2023 Trajenta - EMEA/H/C/002110 - II/0049

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Product information documents contain:

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.

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

Changes since initial authorisation of medicine

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