Komboglyze

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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 30/05/2023

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
20
Date of issue of marketing authorisation valid throughout the European Union
24/11/2011
Contact address

AstraZeneca AB
151 85 Södertälje
Sweden

Product information

30/05/2023 Komboglyze - EMEA/H/C/002059 - IAIN/0055

Other EU languages available icon 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:

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.

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

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