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
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.
Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).