Kirsty (previously Kixelle)

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insulin aspart

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

Kirsty contains the active substance insulin aspart.

This EPAR was last updated on 14/09/2021

Authorisation details

Product details
Name
Kirsty (previously Kixelle)
Agency product number
EMEA/H/C/004965
Active substance
insulin aspart
International non-proprietary name (INN) or common name
insulin aspart
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AB05
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
05/02/2021
Contact address

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Product information

16/07/2021 Kirsty (previously Kixelle) - EMEA/H/C/004965 - IAIN/0001

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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

Assessment history

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