Jentadueto

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linagliptin / metformin hydrochloride

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

Overview

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.

This EPAR was last updated on 03/08/2018

Authorisation details

Product details
Name
Jentadueto
Agency product number
EMEA/H/C/002279
Active substance
  • linagliptin
  • Metformin
International non-proprietary name (INN) or common name
linagliptin / metformin hydrochloride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD11
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
19/07/2012
Contact address
Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Product information

19/07/2018 Jentadueto - EMEA/H/C/002279 - IB/0044/G

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

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.

Assessment history

Changes since initial authorisation of medicine

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