Onglyza

RSS

saxagliptin

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

Overview

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.

This EPAR was last updated on 30/11/2018

Authorisation details

Product details
Name
Onglyza
Agency product number
EMEA/H/C/001039
Active substance
Saxagliptin
International non-proprietary name (INN) or common name
saxagliptin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BH03
Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
30/09/2009
Contact address
151 85 Södertälje
Sweden

Product information

02/08/2018 Onglyza - EMEA/H/C/001039 - WS/1289

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

Add-on combination therapy

Onglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:

as monotherapy:

  • 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.

Assessment history

Changes since initial authorisation of medicine

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