Kirsty (previously Kixelle) (insulin aspart)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- insulin aspart
- Company
- Biosimilar Collaborations Ireland Limited
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Fri 05 Feb 2021
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/004965
- ATC
- A10AB05
- Official record
- www.ema.europa.eu
Indication
Kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Regulatory milestones
No milestones recorded in the last year.
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Follow Kirsty (previously Kixelle)
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.