Ozempic
semaglutide
Table of contents
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.
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 |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
08/02/2018
|
Contact address |
Product information
03/12/2020 Ozempic - EMEA/H/C/004174 - II/0014
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.