saxagliptin / metformin hydrochloride
This is a summary of the European public assessment report (EPAR) for Komboglyze. 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 Komboglyze.
For practical information about using Komboglyze, patients should read the package leaflet or contact their doctor or pharmacist.
Komboglyze : EPAR - Summary for the public (PDF/89.04 KB)
First published: 16/12/2011
Last updated: 02/08/2017
Komboglyze : EPAR - Risk-management-plan summary (PDF/198.3 KB)
First published: 22/03/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Diabetes Mellitus, Type 2
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
151 85 Södertälje
03/03/2021 Komboglyze - EMEA/H/C/002059 - IG/1358/G
- 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.
Drugs used in diabetes
Combinations of oral blood glucose lowering drugs
Komboglyze is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.
Komboglyze is also indicated in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type-2 diabetes mellitus when insulin and metformin alone do not provide adequate glycaemic control.
European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type-2 diabetes26/03/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 201318/01/2013
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201221/09/2012