Qtern (saxagliptin;dapagliflozin)
- Region
- 🇪🇺 EU
- Active substance
- saxagliptin;dapagliflozin
- Company
- Astra Zeneca AB
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2; Diabetes Mellitus; Nutritional and Metabolic Diseases; Metabolic Diseases; Glucose Metabolism Disorders
- EU approval
- Fri 15 Jul 2016
- Application
- EMEA/H/C/004057
- ATC
- A10BD21
- Official record
- www.ema.europa.eu
Indication
Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control, when already being treated with the free combination of dapagliflozin and saxagliptin. (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Qtrilmet Withdrawn · AstraZeneca AB
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.