🇪🇺 Humalog with 50% basal rate reduction in European Union

EMA authorised Humalog with 50% basal rate reduction on 7 May 1997

Marketing authorisations

EMA — authorised 7 May 1997

  • Application: EMEA/H/C/000143
  • Marketing authorisation holder: Eli Lilly and Company Limited
  • Local brand name: Liprolog
  • Indication: For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilization of diabetes mellitus. Liprolog is a short acting insulin and may be used in conjunction with a longer acting human insulin. Liprolog is indicated for preprandial administration.
  • Status: withdrawn

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EMA — authorised 1 August 2001

  • Application: EMEA/H/C/000393
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Liprolog
  • Indication: For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
  • Status: approved

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EMA — authorised 24 March 2020

  • Application: EMEA/H/C/005037
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Lyumjev (previously Liumjev)
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. Treatment of diabetes mellitus in adults.
  • Status: approved

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EMA

  • Application: EMEA/H/C/006158
  • Marketing authorisation holder: Gan & Lee Pharmaceuticals Europe GmbH
  • Local brand name: Bysumlog
  • Indication: Treatment of diabetes mellitus.
  • Pathway: biosimilar
  • Status: approved

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Frequently asked questions

Is Humalog with 50% basal rate reduction approved in European Union?

Yes. EMA authorised it on 7 May 1997; EMA authorised it on 1 August 2001; EMA authorised it on 24 March 2020.

Who is the marketing authorisation holder for Humalog with 50% basal rate reduction in European Union?

Eli Lilly and Company Limited holds the EU marketing authorisation.