Insulin lispro Sanofi
insulin lispro
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Insulin lispro Sanofi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Insulin lispro Sanofi.
For practical information about using Insulin lispro Sanofi, patients should read the package leaflet or contact their doctor or pharmacist.
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Insulin lispro Sanofi : EPAR - Summary for the public (PDF/76.56 KB)
First published: 22/09/2017
Last updated: 22/09/2017
EMA/353032/2017 -
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Insulin lispro Sanofi : EPAR - Risk-management-plan summary (PDF/367.14 KB)
First published: 07/04/2022
Authorisation details
Product details | |
---|---|
Name |
Insulin lispro Sanofi
|
Agency product number |
EMEA/H/C/004303
|
Active substance |
insulin lispro
|
International non-proprietary name (INN) or common name |
insulin lispro
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
A10AB04
|
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 | |
---|---|
Marketing-authorisation holder |
Sanofi Winthrop Industrie
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
19/07/2017
|
Contact address |
82 Avenue Raspail |
Product information
06/07/2023 Insulin lispro Sanofi - EMEA/H/C/004303 - N/0017
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
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.