🇪🇺 Canagliflozin - SGLT2i in European Union

EMA authorised Canagliflozin - SGLT2i on 15 November 2013

Marketing authorisation

EMA — authorised 15 November 2013

  • Application: EMEA/H/C/002649
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Invokana
  • Indication: Invokana is indicated for the treatment of adults and children aged 10 years and older with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:  as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of 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.
  • Status: approved

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Canagliflozin - SGLT2i in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Diabetes approved in European Union

Frequently asked questions

Is Canagliflozin - SGLT2i approved in European Union?

Yes. EMA authorised it on 15 November 2013.

Who is the marketing authorisation holder for Canagliflozin - SGLT2i in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.