Ozempic

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semaglutide

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

Overview

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

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

This EPAR was last updated on 31/07/2018

Authorisation details

Product details
Name
Ozempic
Agency product number
EMEA/H/C/004174
Active substance
semaglutide
International non-proprietary name (INN) or common name
semaglutide
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10BJ06
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
1
Date of issue of marketing authorisation valid throughout the European Union
07/02/2018
Contact address
Novo Alle 1
2880 Bagsvaerd
Denmark

Product information

30/05/2018 Ozempic - EMEA/H/C/004174 - II/0002/G

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

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, see sections 4.4, 4.5 and 5.1.

Assessment history

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