Insulin lispro Sanofi

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insulin lispro

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

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.

This EPAR was last updated on 07/07/2023

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
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
Sanofi Winthrop Industrie
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
19/07/2017
Contact address

82 Avenue Raspail
94250 Gentilly
FRANCE

Product information

06/07/2023 Insulin lispro Sanofi - EMEA/H/C/004303 - N/0017

Other EU languages available icon 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:

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.

Assessment history

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