This is a summary of the European public assessment report (EPAR) for Onglyza. 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 Onglyza.
For practical information about using Onglyza, patients should read the package leaflet or contact their doctor or pharmacist.
Onglyza : EPAR - Summary for the public (PDF/87.11 KB)
First published: 27/10/2009
Last updated: 31/07/2017
Onglyza : EPAR - Risk-management-plan summary (PDF/188.15 KB) (new)
First published: 16/04/2021
|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 Onglyza - EMEA/H/C/001039 - 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
Add-on combination therapy
Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:
- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;
as dual oral therapy:
- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
- in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;
- in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;
as triple oral therapy:
- in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;
as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does 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 October 201121/10/2011