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 14/05/2018

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
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
Marketing-authorisation holder
sanofi-aventis groupe
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
19/07/2017
Contact address
54 rue La Boetie
75008 Paris
France

Product information

03/04/2018 Insulin lispro Sanofi - EMEA/H/C/004303 - IB/0002

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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