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EMA Product

Kirsty (previously Kixelle)

Product approved by European Medicines Agency (EU)

Basic Information

Kirsty (previously Kixelle)

Regulatory Information

EMEA/H/C/004965

Authorised

February 5, 2021

December 10, 2020

4

September 27, 2023

Company Information

Ireland

Unit 35/36 Grange Parade, Baldoyle Industrial Estate Dublin 13 DUBLIN D13 R20R

Biosimilar Collaborations Ireland Ltd.

Drug Classification

Biosimilar MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Overview Summary

Kirsty is a medicine used to control blood glucose (sugar) levels in patients from one year of age who have diabetes. Kirsty is a ‘biosimilar medicine’. This means that Kirsty is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Kirsty is NovoRapid. For more information on biosimilar medicines, see [here](/en/outdated-human-medicines-regulatory-information). Kirsty contains the active substance insulin aspart.

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