Insulin lispro Sanofi

insulin lispro

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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.

What is Insulin lispro Sanofi and what is it used for?

Insulin lispro Sanofi is a medicine used to control blood glucose (sugar) levels in adults and children with diabetes who need insulin. It contains the active substance insulin lispro.

Insulin lispro Sanofi is a ‘biosimilar medicine’. This means that it is highly similar to a biological medicine (also known as the ‘reference medicine’) that is already authorised in the European Union (EU). The reference medicine for Insulin lispro Sanofi is Humalog 100 U/ml solution.

How is Insulin lispro Sanofi used?

Insulin lispro Sanofi is given as an injection under the skin in the upper arm, thigh, buttock or belly. It can also be given with an infusion pump. In some circumstances, such as when blood acid levels are dangerously high (ketoacidosis), the medicine may be given into a vein.

Because Insulin lispro Sanofi is a fast-acting insulin, it is usually given shortly before a meal and, when necessary, soon after a meal. The dose of Insulin lispro Sanofi is worked out for each patient and depends on the patient’s blood glucose level. The doctor should instruct the patient on how to use the medicine properly.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Insulin lispro Sanofi work?

In diabetes, patients have high levels of blood glucose either because the body does not produce enough insulin or the body is unable to use insulin effectively.

The active substance in Insulin lispro Sanofi is a form of insulin which is absorbed more quickly by the body than human regular insulin, and can therefore act faster. It helps control blood glucose levels, thereby alleviating symptoms and reducing the risk of complications of diabetes.

What benefits of Insulin lispro Sanofi have been shown in studies?

Laboratory studies comparing Insulin lispro Sanofi with the reference medicine Humalog have shown that the active substance in Insulin lispro Sanofi is highly similar in terms of structure, purity and biological activity to that of Humalog. In addition, studies have shown that both medicines produce similar levels of the active substance in the body.

Two further studies in a total of 1,012 patients compared Insulin lispro Sanofi with Humalog and found them to be similarly effective at reducing blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose levels are controlled over time. In one study, in patients with type 1 diabetes, HbA1c reduced by 0.44 and 0.46 percentage points with Insulin lispro Sanofi and Humalog respectively after 26 weeks; in the second study, in patients with type 2 diabetes, the corresponding figures were 0.93 versus 0.88 percentage points.

What are the risks associated with Insulin lispro Sanofi?

Insulin lispro Sanofi may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low. Severe hypoglycaemia can lead to loss of consciousness and, in very extreme cases, to death. Hypoglycaemia may be due to the medicine itself or other factors such as diet and exercise.

For the full list of all side effects and restrictions with Insulin lispro Sanofi, see the package leaflet.

Why is Insulin lispro Sanofi approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements for biosimilar medicines, Insulin lispro Sanofi has a highly similar structure, purity and biological activity to Humalog and is distributed in the body in the same way. In addition, studies show that both medicines have similar effects in reducing blood glucose levels and similar side effects. Therefore, the CHMP’s view was that, as for Humalog, the benefits of Insulin lispro Sanofi outweigh its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Insulin lispro Sanofi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Insulin lispro Sanofi have been included in the summary of product characteristics and the package leaflet.

Other information about Insulin lispro Sanofi

The European Commission granted a marketing authorisation valid throughout the European Union for Insulin lispro Sanofi on 19 July 2017.

For more information about treatment with Insulin lispro Sanofi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Insulin lispro Sanofi : EPAR - Summary for the public BG = bălgarski 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public ES = español 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public CS = čeština 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public DA = dansk 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public DE = Deutsch 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public ET = eesti keel 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public EL = elliniká 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public EN = English 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public FR = français 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public IT = italiano 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public LV = latviešu valoda 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public LT = lietuvių kalba 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public HU = magyar 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public MT = Malti 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public NL = Nederlands 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public PL = polski 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public PT = português 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public RO = română 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public SK = slovenčina 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public SL = slovenščina 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public FI = suomi 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public SV = svenska 2017-09-22  
Insulin lispro Sanofi : EPAR - Summary for the public HR = Hrvatski 2017-09-22  

This EPAR was last updated on 06/11/2017 .

Authorisation details

Product details

Product details for Insulin lispro Sanofi
NameInsulin lispro Sanofi
Agency product numberEMEA/H/C/004303
Active substance

insulin lispro

International non-proprietary name (INN) or common name

insulin lispro

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AB04
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Insulin lispro Sanofi
Marketing-authorisation holder

sanofi-aventis groupe

Revision1
Date of issue of marketing authorisation valid throughout the European Union19/07/2017

Contact address:

sanofi-aventis groupe
54 rue La Boetie 
75008 Paris 
France
 

Product information

Product information

29/08/2017  Insulin lispro Sanofi -EMEA/H/C/004303 -IAIN/0001/G

Name Language First published Last updated
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06
Insulin lispro Sanofi : EPAR - Product Information HR = Hrvatski 2017-09-22 2017-11-06

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.


Name Language First published Last updated
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  
Insulin lispro Sanofi : EPAR - All Authorised presentations HR = Hrvatski 2017-09-22  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Insulin lispro Sanofi : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-11-06  

Initial marketing-authorisation documents

Name Language First published Last updated
Insulin lispro Sanofi : EPAR - Public assessment report HR = Hrvatski 2017-09-22  
CHMP summary of positive opinion for Insulin lispro Sanofi HR = Hrvatski 2017-05-19  

Authorised

This medicine is approved for use in the European Union

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