Victoza

liraglutide

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

For practical information about using Victoza, patients should read the package leaflet or contact their doctor or pharmacist.

What is Victoza and what is it used for?

Victoza is a medicine used in addition to diet and exercise in adults who have type 2 diabetes.

Victoza is used:

  • on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;
  • as an ‘add-on’ to other diabetes medicines.

Victoza contains the active substance liraglutide.

How is Victoza used?

Victoza is a solution for injection available in pre‑filled pens (6 mg/ml). Victoza is given by the patient once a day by 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).

The medicine can only be obtained with a prescription.

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.

What benefits of Victoza have been shown in studies?

Victoza was effective at controlling blood glucose in six main studies involving 4,155 adults with type 2 diabetes. In these studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called glycosylated haemoglobin (HbA1c) after six months or one year of treatment. HbA1c gives an indication of how well the blood glucose is controlled.

In one ‘monotherapy’ study, Victoza on its own was compared with glimepiride (a sulphonylurea). Victoza used on its own was more effective at controlling blood glucose than glimepiride. Results from this study show that Victoza at a dose of 1.2 mg reduced HbA1c by 0.8 percentage points, whereas Victoza at a dose of 1.8 mg led to reductions of 1.1 percentage points. This compared with a reduction of 0.5 percentage points with glimepiride.

In two ‘dual therapy’ studies, Victoza plus metformin or Victoza plus glimepiride were compared with metformin or glimepiride taken with a placebo (a dummy treatment). Combinations containing Victoza were more effective at controlling blood glucose than combinations without the medicine. Dual therapies containing Victoza and metformin or glimepiride led to reductions in HbA1c of around 1 percentage point compared with no reduction without Victoza.

In two ‘triple therapy’ studies, Victoza with metformin and either glimepiride or rosiglitazone (a thiazolidinedione) were compared with treatments that included placebo or another anti‑diabetes medicine instead of Victoza. The triple therapies containing Victoza 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.

In another triple therapy study, Victoza was compared with a single dose of a short-acting insulin, insulin aspart, when added to treatment with basal insulin (a long-acting insulin) plus metformin. Adding Victoza to treatment with basal insulin plus metformin reduced HbA1c by 0.7 percentage points, compared with 0.4 points when adding Victoza to insulin aspart.

In addition to the above studies, Victoza was shown to be effective in reducing adverse cardiovascular (heart and blood vessels) effects. The study involved 9,340 patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack or stroke). The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease. Victoza was compared with placebo and all patients also received standard care. Patients were followed up on average for 3.8 years. Cardiovascular events occurred in 13% (608 out of 4668) of patients taking Victoza compared with 14.9% (694 out of 4672) of patients taking placebo.

What are the risks associated with Victoza?

The most common side effects with Victoza (seen in more than 1 patient in 10) are nausea and diarrhoea. These side effects usually pass after a few days or weeks of treatment. For the full list of all side effects and restrictions with Victoza, see the package leaflet.

What are the risks associated with Victoza?

The most common side effects with Victoza (seen in more than 1 patient in 10) are nausea and diarrhoea. These side effects usually pass after a few days or weeks of treatment. For the full list of all side effects and restrictions with Victoza, see the package leaflet.

Why is Victoza approved?

The European Medicines Agency decided that Victoza’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 Victoza?

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

Other information about Victoza

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

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

Name Language First published Last updated
Victoza : EPAR - Summary for the public BG = bălgarski 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public ES = español 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public CS = čeština 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public DA = dansk 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public DE = Deutsch 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public ET = eesti keel 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public EL = elliniká 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public EN = English 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public FR = français 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public IT = italiano 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public LV = latviešu valoda 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public LT = lietuvių kalba 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public HU = magyar 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public MT = Malti 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public NL = Nederlands 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public PL = polski 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public PT = português 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public RO = română 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public SK = slovenčina 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public SL = slovenščina 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public FI = suomi 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public SV = svenska 2009-07-08 2017-09-14
Victoza : EPAR - Summary for the public HR = Hrvatski 2009-07-08 2017-09-14

This EPAR was last updated on 14/09/2017 .

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

Revision17
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

25/07/2016  Victoza -EMEA/H/C/001026 -II/0042

Name Language First published Last updated
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14
Victoza : EPAR - Product Information HR = Hrvatski 2009-07-08 2017-09-14

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

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Victoza is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
•         as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
•         in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied.

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 2009-07-09  
Committee for medicinal products for human use, summary of positive opinion for Victoza HR = Hrvatski 2009-04-23  

Authorised

This medicine is approved for use in the European Union

More information on Victoza