Insulin aspart Sanofi
insulin aspart
Table of contents
Overview
Insulin aspart Sanofi is a medicine used to control blood glucose (sugar) levels in patients from one year of age who have diabetes.
Insulin aspart Sanofi is a ‘biosimilar medicine’. This means that Insulin aspart Sanofi is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Insulin aspart Sanofi is NovoRapid.
Insulin aspart Sanofi contains the active substance insulin aspart, a rapid-acting insulin.
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Insulin aspart Sanofi : EPAR - Medicine overview (PDF/123.67 KB)
First published: 07/07/2020
EMA/242544/2020 -
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Insulin aspart Sanofi : EPAR - Risk-management-plan summary (PDF/20.14 KB)
First published: 07/07/2020
Authorisation details
Product details | |
---|---|
Name |
Insulin aspart Sanofi
|
Agency product number |
EMEA/H/C/005033
|
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
|
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 |
Sanofi Winthrop Industrie
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
25/06/2020
|
Contact address |
82 Avenue Raspail |
Product information
06/07/2023 Insulin aspart Sanofi - EMEA/H/C/005033 - N/0014
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
Insulin aspart Sanofi is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.