Kirsty (previously Kixelle)
insulin aspart
Table of contents
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.
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Kirsty (previously Kixelle) : EPAR - Medicine overview (PDF/103.42 KB)
First published: 16/03/2021
Last updated: 14/09/2021
EMA/704954/2020 -
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Kixelle : EPAR - Risk-management-plan summary (PDF/83.16 KB)
First published: 16/03/2021
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 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. |
Biosimilar |
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 | |
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Marketing-authorisation holder |
Biosimilar Collaborations Ireland Limited
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
05/02/2021
|
Contact address |
Unit 35/36 |
Product information
30/11/2023 Kirsty (previously Kixelle) - EMEA/H/C/004965 - IAIN/0013
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.