🇪🇺 Gla-100 (insulin glargine) in European Union

EMA authorised Gla-100 (insulin glargine) on 9 June 2000

Marketing authorisation

EMA — authorised 9 June 2000

  • Application: EMEA/H/C/000284
  • Marketing authorisation holder: sanofi-aventis Deutschland GmbH
  • Local brand name: Lantus
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children aged two years and above
  • Status: approved

Read official source →

Other Diabetes approved in European Union

Frequently asked questions

Is Gla-100 (insulin glargine) approved in European Union?

Yes. EMA authorised it on 9 June 2000.

Who is the marketing authorisation holder for Gla-100 (insulin glargine) in European Union?

sanofi-aventis Deutschland GmbH holds the EU marketing authorisation.