indacaterol / glycopyrronium bromide
This is a summary of the European public assessment report (EPAR) for Xoterna Breezhaler. It explains how the European Medicines Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Xoterna Breezhaler.
For practical information about using Xoterna Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Xoterna Breezhaler : EPAR - Summary for the public (PDF/77.11 KB)
First published: 04/10/2013
Last updated: 04/10/2013
Xoterna Breezhaler : EPAR - Risk-management-plan summary (PDF/118.73 KB)
First published: 04/05/2018
Last updated: 02/08/2019
|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 Xoterna Breezhaler - EMEA/H/C/003755 - IG/1424/G
- 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.
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).