🇪🇺 Empagliflozin Pill in European Union

EMA authorised Empagliflozin Pill on 11 November 2016

Marketing authorisation

EMA — authorised 11 November 2016

  • Application: EMEA/H/C/003833
  • Marketing authorisation holder: Boehringer Ingelheim International GmbH
  • Local brand name: Glyxambi
  • Indication: Glyxambi, fixed dose combination of empagliflozin and linagliptin, 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 Glyxambi do not provide adequate glycaemic control; when already being treated with the free combination of empagliflozin and linagliptin.
  • Status: approved

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Other Diabetes approved in European Union

Frequently asked questions

Is Empagliflozin Pill approved in European Union?

Yes. EMA authorised it on 11 November 2016.

Who is the marketing authorisation holder for Empagliflozin Pill in European Union?

Boehringer Ingelheim International GmbH holds the EU marketing authorisation.