🇪🇺 Insulin Lispro SAR342434 in European Union

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EMA authorised Insulin Lispro SAR342434 on 19 July 2017

Marketing authorisation

EMA — authorised 19 July 2017

Application: EMEA/H/C/004303
Marketing authorisation holder: Sanofi Winthrop Industrie
Local brand name: Insulin lispro Sanofi
Indication: For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.
Pathway: biosimilar
Status: approved

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Frequently asked questions

Is Insulin Lispro SAR342434 approved in European Union?

Yes. EMA authorised it on 19 July 2017.

Who is the marketing authorisation holder for Insulin Lispro SAR342434 in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.