🇪🇺 Dapagliflozin (DAPA) in European Union

EMA authorised Dapagliflozin (DAPA) on 9 November 2015

Marketing authorisations

EMA — authorised 9 November 2015

  • Application: EMEA/H/C/004161
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Edistride
  • Indication: Type 2 diabetes mellitus Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Edistride is indicated in adults for the tr
  • Status: approved

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EMA — authorised 15 November 2015

  • Application: EMEA/H/C/004162
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Ebymect
  • Indication: Type 2 diabetes mellitus For the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. 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. Type 1 diabetes mellitus Edistride is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as
  • Status: approved

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EMA — authorised 24 March 2023

  • Application: EMEA/H/C/006006
  • Marketing authorisation holder: Viatris Limited
  • Local brand name: Dapagliflozin Viatris
  • Indication: Type 2 diabetes mellitus Dapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Dapagliflozin Viatris is indi
  • Status: approved

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Frequently asked questions

Is Dapagliflozin (DAPA) approved in European Union?

Yes. EMA authorised it on 9 November 2015; EMA authorised it on 15 November 2015; EMA authorised it on 24 March 2023.

Who is the marketing authorisation holder for Dapagliflozin (DAPA) in European Union?

AstraZeneca AB holds the EU marketing authorisation.