empagliflozin / linagliptin
Table of contents
This is a summary of the European public assessment report (EPAR) for Glyxambi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Glyxambi.
For practical information about using Glyxambi, patients should read the package leaflet or contact their doctor or pharmacist.
Glyxambi : EPAR - Summary for the public (PDF/83.96 KB)
First published: 24/11/2016
Last updated: 24/11/2016
Glyxambi : EPAR - Risk-management-plan summary (PDF/71.1 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||
Binger Strasse 173 55216
Ingelheim am Rhein
13/04/2022 Glyxambi - EMEA/H/C/003833 - IAIN/0046
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.
Drugs used in diabetes
Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:
- to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;
- when already being treated with the free combination of empagliflozin and linagliptin.