This is a summary of the European public assessment report (EPAR) for Onbrez Breezhaler. 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 Onbrez Breezhaler.
For practical information about using Onbrez Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Onbrez Breezhaler : EPAR - Summary for the public (PDF/98.36 KB)
First published: 05/01/2010
Last updated: 12/10/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Pulmonary Disease, Chronic Obstructive
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
10/12/2020 Onbrez Breezhaler - EMEA/H/C/001114 - WS/1931
- 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.
Drugs for obstructive airway diseases
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.