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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
N/AATC Code
A10BD10
ATC Item
metformin and saxagliptin
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
N/AINN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| metformin hydrochloride | N/A | 二甲双胍 |
| saxagliptin hydrochloride | N/A | Dapagliflozin/Metformin Hydrochloride/Saxagliptin Hydrochloride |
EMA Name
Komboglyze
Medicine Name
Komboglyze
Aliases
N/ANo risk management plan link.
