Table of contents
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.
Ozempic : EPAR - Summary for the public (PDF/76.14 KB)
First published: 21/02/2018
Last updated: 21/02/2018
Ozempic : EPAR - Risk management plan summary (PDF/327.8 KB)
First published: 23/02/2022
Last updated: 22/06/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
Novo Nordisk A/S
|Date of issue of marketing authorisation valid throughout the European Union||
Novo Alle 1
31/03/2023 Ozempic - EMEA/H/C/004174 - PSUSA/00010671/202205
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Drugs used in diabetes
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.