linagliptin / metformin hydrochloride

This medicine is authorised for use in the European Union.


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 09/04/2021

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Boehringer Ingelheim International GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Binger Strasse 173
D-55216 Ingelheim am Rhein

Product information

18/03/2021 Jentadueto - EMEA/H/C/002279 - N/0061


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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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