🇪🇺 Insulin degludec 100 U/mL in European Union

EMA authorised Insulin degludec 100 U/mL on 20 January 2013

Marketing authorisation

EMA — authorised 20 January 2013

  • Application: EMEA/H/C/002498
  • Marketing authorisation holder: Novo Nordisk A/S
  • Local brand name: Tresiba
  • Indication: Treatment of diabetes mellitus in adults.
  • Status: approved

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Other Diabetes approved in European Union

Frequently asked questions

Is Insulin degludec 100 U/mL approved in European Union?

Yes. EMA authorised it on 20 January 2013.

Who is the marketing authorisation holder for Insulin degludec 100 U/mL in European Union?

Novo Nordisk A/S holds the EU marketing authorisation.