Komboglyze

RSS

saxagliptin / metformin hydrochloride

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

Overview

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.

This EPAR was last updated on 09/01/2018

Authorisation details

Product details
Name
Komboglyze
Agency product number
EMEA/H/C/002059
Active substance
metformin hydrochloride / saxagliptin hydrochloride
International non-proprietary name (INN) or common name
saxagliptin / metformin hydrochloride
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BD10
Publication details
Marketing-authorisation holder
AstraZeneca AB 
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
23/11/2011
Contact address
AstraZeneca AB
151 85 Södertälje
Sweden

Product information

25/06/2017 Komboglyze - EMEA/H/C/002059 - WS/1078

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

  • Combinations of oral blood glucose lowering drugs

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating