Xigduo (dapagliflozin;metformin)
- Region
- 🇪🇺 EU
- Active substance
- dapagliflozin;metformin
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus, Type 2
- CHMP opinion
- Wed 20 Nov 2013
- EU approval
- Thu 16 Jan 2014
- Application
- EMEA/H/C/002672
- ATC
- A10BD15
- Official record
- www.ema.europa.eu
Indication
Xigduo is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: • in patients insufficiently controlled on their maximally tolerated dose of metformin alone • in combination with other medicinal products for the treatment of diabetes in patients insufficiently controlled with metformin and these medicinal products • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets. For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ebymect Authorised · 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.