🇪🇺 Dapagliflozin/Metformin in European Union

EMA authorised Dapagliflozin/Metformin on 16 January 2014

Marketing authorisation

EMA — authorised 16 January 2014

  • Application: EMEA/H/C/002672
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Xigduo
  • 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
  • Status: approved

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Other Diabetes approved in European Union

Frequently asked questions

Is Dapagliflozin/Metformin approved in European Union?

Yes. EMA authorised it on 16 January 2014.

Who is the marketing authorisation holder for Dapagliflozin/Metformin in European Union?

AstraZeneca AB holds the EU marketing authorisation.