Komboglyze (saxagliptin;metformin hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- saxagliptin;metformin hydrochloride
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- EU approval
- Thu 24 Nov 2011
- Application
- EMEA/H/C/002059
- ATC
- A10BD10
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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