Victoza

RSS

liraglutide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 07/02/2018

Authorisation details

Product details
Name
Victoza
Agency product number
EMEA/H/C/001026
Active substance
liraglutide
International non-proprietary name (INN) or common name
liraglutide
Therapeutic area (MeSH)
Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code
A10BJ02
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
30/06/2009
Contact address
Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

22/09/2017 Victoza - EMEA/H/C/001026 - IA/0045

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

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

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