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||
06/08/2021 Onbrez Breezhaler - EMEA/H/C/001114 - IG1424/G
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 for obstructive airway diseases
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.