Saxenda

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 Saxenda. 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 Saxenda.

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

This EPAR was last updated on 25/07/2018

Authorisation details

Product details
Name
Saxenda
Agency product number
EMEA/H/C/003780
Active substance
liraglutide
International non-proprietary name (INN) or common name
liraglutide
Therapeutic area (MeSH)
  • Obesity
  • Overweight
Anatomical therapeutic chemical (ATC) code
A10BJ02
Additional monitoring

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

Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
23/03/2015
Contact address
Novo Alle
2880 Bagsvaerd
Denmark

Product information

28/06/2018 Saxenda - EMEA/H/C/003780 - II/0018

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

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of

• ≥ 30 kg/m² (obese), or
• ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.

Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.

Assessment history

How useful was this page?

Add your rating