Levemir

insulin detemir

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This is a summary of the European public assessment report (EPAR) for Levemir. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levemir.

What is Levemir?

Levemir is a solution for injection that contains the active substance insulin detemir. It is available in cartridges and in pre-filled pens.

What is Levemir used for?

Levemir is used to treat diabetes in adults, adolescents and children over the age of two years. 

The medicine can only be obtained with a prescription.

How is Levemir used?

Levemir is given as an injection under the skin in the abdominal (tummy) wall, the thigh, the upper arm, the shoulder or the buttock. Levemir is a long-acting insulin. It can be used in the following ways:

  • alone as basal insulin;
  • in combination with injections of a short- or rapid-acting insulin at mealtimes;
  • in combination with diabetes medicines taken by mouth;
  • in combination with a type of diabetes medicines called GLP-1 receptor agonists that are given by injection. When a GLP-1 receptor agonist is added to Levemir, the Levemir dose should be reduced, and subsequently adjusted according to the individual patient’s blood glucose levels.

Levemir can be given at any time of day, provided that it is the same time each day. The dose of Levemir should be adjusted according to the individual patient’s blood glucose (sugar) levels, which should be regularly tested to find the lowest effective dose.

How does Levemir work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Levemir is a replacement insulin that is very similar to the insulin made by the body.

Insulin detemir is very slightly different from human insulin. The change means that it is absorbed more slowly by the body, and takes longer to reach its target in the body. This means that Levemir has a long duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Levemir been studied?

Levemir has been studied in 1,575 adult patients with type 1 diabetes (when the pancreas cannot produce insulin) and over 2,500 adult patients with type 2 diabetes (when the body is unable to use insulin effectively). The studies compared Levemir with human insulin NPH (an intermediate-acting insulin) or insulin glargine (a long-acting insulin) given once or twice a day. Injections of fast-acting insulin were also used at mealtimes. In four of the six studies in type 2 diabetes, patients also received one or two antidiabetes medicines taken by mouth.

Levemir has also been studied in two main studies involving 695 children and adolescents with diabetes aged 2-17 years in combination with insulin aspart and comparing it to insulin NPH.

The effects of Levemir have also been studied in combination with metformin and liraglutide (a GLP-1 receptor agonist). In one study, 323 patients with type 2 diabetes whose blood glucose levels were not well controlled with metformin and liraglutide either received Levemir in addition to their treatment or continued on metformin and liraglutide alone.

All of the studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. Levemir has not been studied in children below two years of age.

What benefit has Levemir shown during the studies?

The studies showed that Levemir controls blood glucose levels in a similar manner to insulin NPH, with less risk of low blood glucose levels during the night and no associated weight gain. In combination with diabetes medicines taken by mouth, Levemir also controlled blood glucose levels in a similar manner to insulin glargine. Patients using Levemir in combination with liraglutide and metformin achieved a decrease of 0.5% in Hb1Ac compared with no decrease in patients using liraglutide and metformin alone. Additionally the weight benefit from liraglutide was sustained when adding Levemir.

What is the risk associated with Levemir?

The most common side effect with Levemir (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects and restrictions with Levemir, see the package leaflet.

Levemir doses might need to be adjusted when given with some other medicines that may have an effect on blood glucose levels. The full list is available in the package leaflet.

Why has Levemir been approved?

The CHMP decided that Levemir’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Levemir?

A risk management plan has been developed to ensure that Levemir is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levemir, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Levemir

The European Commission granted a marketing authorisation valid throughout the European Union for Levemir on 1 June 2004.

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

Name Language First published Last updated
Levemir : EPAR - Summary for the public BG = bălgarski 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public ES = español 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public CS = čeština 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public DA = dansk 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public DE = Deutsch 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public ET = eesti keel 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public EL = elliniká 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public EN = English 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public FR = français 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public IT = italiano 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public LV = latviešu valoda 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public LT = lietuvių kalba 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public HU = magyar 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public MT = Malti 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public NL = Nederlands 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public PL = polski 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public PT = português 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public RO = română 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public SK = slovenčina 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public SL = slovenščina 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public FI = suomi 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public SV = svenska 06/08/2009 29/07/2015
Levemir : EPAR - Summary for the public HR = Hrvatski 06/08/2009 29/07/2015

This EPAR was last updated on 29/07/2015 .

Authorisation details

Product details

Product details for Levemir
NameLevemir
Agency product numberEMEA/H/C/000528
Active substance

insulin detemir

International non-proprietary name (INN) or common name

insulin detemir

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AE05

Publication details

Publication details for Levemir
Marketing-authorisation holder

Novo Nordisk A/S

Revision20
Date of issue of marketing authorisation valid throughout the European Union01/06/2004

Contact address:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

Product information

23/04/2015  Levemir -EMEA/H/C/000528 -II/0071

Name Language First published Last updated
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015
Levemir : EPAR - Product Information HR = Hrvatski 15/06/2009 29/07/2015

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
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012
Levemir : EPAR - All Authorised presentations HR = Hrvatski 15/08/2006 06/01/2012

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Levemir : EPAR - Procedural steps taken before authorisation HR = Hrvatski 15/08/2006  
Levemir : EPAR - Scientific Discussion HR = Hrvatski 15/08/2006  

Authorised

This medicine is approved for use in the European Union

More information on Levemir