Victoza

liraglutide

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This is a summary of the European public assessment report (EPAR) for Victoza. 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 Victoza.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Victoza?

Victoza is a solution for injection that contains the active substance liraglutide. It is available in pre- filled pens (6 mg/ml).

What is Victoza used for?

Victoza is used in adults who have type 2 diabetes (non-insulin-dependent diabetes) to control their blood glucose (sugar) level. Victoza is used as an ‘add-on’ to other diabetes medicines and/or basal insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose. Basal insulin is a long-acting background insulin.

The medicine can only be obtained with a prescription.

How is Victoza used?

Victoza is administered by the patient once a day by subcutaneous injection (under the skin) in the abdomen, thigh or upper arm. It is given independent of meals and preferably at the same time each day.

The starting dose of Victoza is 0.6 mg. After at least one week, the dose is increased to 1.2 mg. In some patients, the dose can be further increased to 1.8 mg one week later to achieve better control of blood glucose.

When Victoza is added to existing treatment containing metformin or a thiazolidinedione, the doses of these medicines do not have to be changed. When Victoza is added to treatment with a sulphonylurea or insulin, the doctor should consider lowering the dose of the other medicine to reduce the risk of having hypoglycaemia (low blood glucose).

How does Victoza work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively. The active substance in Victoza, liraglutide, is an ‘incretin mimetic’. This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food. This helps with the control of blood glucose levels.

How has Victoza been studied?

Victoza was investigated in six main studies involving 4,155 adults with type 2 diabetes:

  • one ‘monotherapy’ study, comparing Victoza on its own with glimepiride (a sulphonylurea);
  • two ‘dual therapy’ studies comparing Victoza plus metformin or Victoza plus glimepiride with metformin or glimepiride taken with a placebo (a dummy treatment);
  • two ‘triple therapy’ studies comparing Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione), with treatments that included placebo or another anti‑diabetes medicine instead of Victoza;
  • another triple therapy study comparing Victoza with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin plus metformin.

The main measure of effectiveness was the change in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c) after six months or one year. HbA1c gives an indication of how well the blood glucose is controlled.

What benefit has Victoza shown during the studies?

Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine. Dual therapies containing Victoza and metformin or a sulphonylurea led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza. Triple therapies containing metformin and either a sulphonylurea or a thiazolidinedione led to a reduction of between 1.3 and 1.5 percentage points compared with a reduction equal or less than 0.5 points without Victoza. Similarly, adding Victoza to treatment with basal insulin plus metformin reduced HbA1c by 0.7 percentage points, compared with 0.4 points when a dose of insulin aspart was added. When used alone there was also a greater reduction in HbA1c with Victoza than with glimepiride. However, the study was not sufficient to support the use of Victoza as a monotherapy.

What is the risk associated with Victoza?

The most common side effects with Victoza used in combination with other anti-diabetes medicines (seen in more than 1 patient in 10) are hypoglycaemia (low blood glucose), headache, nausea and diarrhoea.For the full list of all side effects and restrictions with Victoza, see the package leaflet.

Why has Victoza been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Victoza’s benefits are greater than its risks for use with other diabetes medicines, including insulin, to achieve control of blood sugar in adults with type 2 diabetes mellitus. The Committee recommended that Victoza be given marketing authorisation.

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

A risk management plan has been developed to ensure that Victoza 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 Victoza, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Victoza

The European Commission granted a marketing authorisation valid throughout the European Union for Victoza on 30 June 2009.

Name Language First published Last updated
Victoza : EPAR - Summary for the public BG = bălgarski 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public ES = español 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public CS = čeština 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public DA = dansk 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public DE = Deutsch 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public ET = eesti keel 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public EL = elliniká 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public EN = English 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public FR = français 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public IT = italiano 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public LV = latviešu valoda 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public LT = lietuvių kalba 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public HU = magyar 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public MT = Malti 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public NL = Nederlands 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public PL = polski 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public PT = português 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public RO = română 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public SK = slovenčina 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public SL = slovenščina 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public FI = suomi 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public SV = svenska 08/07/2009 26/06/2014
Victoza : EPAR - Summary for the public HR = Hrvatski 08/07/2009 26/06/2014

This EPAR was last updated on 26/06/2014 .

Authorisation details

Product details

Product details for Victoza
NameVictoza
Agency product numberEMEA/H/C/001026
Active substance

liraglutide

International non-proprietary name (INN) or common name

liraglutide

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BX07

Publication details

Publication details for Victoza
Marketing-authorisation holder

Novo Nordisk A/S

Revision9
Date of issue of marketing authorisation valid throughout the European Union30/06/2009

Contact address:

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

Product information

Product information

28/04/2014  Victoza -EMEA/H/C/001026 -II/0023

Name Language First published Last updated
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014
Victoza : EPAR - Product Information HR = Hrvatski 08/07/2009 26/06/2014

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
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  
Victoza : EPAR - All Authorised presentations HR = Hrvatski 08/07/2009  

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Victoza is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Victoza : EPAR - Public assessment report HR = Hrvatski 09/07/2009  
Committee for medicinal products for human use, summary of positive opinion for Victoza HR = Hrvatski 23/04/2009  

Authorised

This medicine is approved for use in the European Union

More information on Victoza