🇪🇺 GP40071 in European Union

EMA authorised GP40071 on 25 June 2020

Marketing authorisations

Application: EMEA/H/C/005033
Marketing authorisation holder: Sanofi Winthrop Industrie
Local brand name: Insulin aspart Sanofi
Indication: Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Pathway: biosimilar
Status: approved

Application: EMEA/H/C/004965
Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
Local brand name: Kirsty (previously Kixelle)
Indication: Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Pathway: biosimilar
Status: approved

Application: EMEA/H/C/005635
Marketing authorisation holder: Sanofi Winthrop Industrie
Local brand name: Truvelog Mix 30
Indication: Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.
Pathway: biosimilar
Status: withdrawn

Is GP40071 approved in European Union?

Yes. EMA authorised it on 25 June 2020; EMA authorised it on 5 February 2021; EMA authorised it on 25 April 2022.

Who is the marketing authorisation holder for GP40071 in European Union?

Sanofi Winthrop Industrie holds the EU marketing authorisation.