🇪🇺 Sitagliptin + Metformin in European Union

EMA authorised Sitagliptin + Metformin on 16 July 2008

Marketing authorisation

EMA — authorised 16 July 2008

  • Application: EMEA/H/C/000861
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Janumet
  • Indication: For patients with type 2 diabetes mellitus: Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin. Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. Janumet is indicated as triple combination therapy with a PPAR  agonist
  • Status: approved

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Other Diabetes approved in European Union

Frequently asked questions

Is Sitagliptin + Metformin approved in European Union?

Yes. EMA authorised it on 16 July 2008.

Who is the marketing authorisation holder for Sitagliptin + Metformin in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.