Xoterna Breezhaler


indacaterol / glycopyrronium bromide

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 07/09/2021

Authorisation details

Product details
Xoterna Breezhaler
Agency product number
Active substance
  • indacaterol
  • glycopyrronium bromide
International non-proprietary name (INN) or common name
  • indacaterol
  • glycopyrronium bromide
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4

Product information

06/08/2021 Xoterna Breezhaler - EMEA/H/C/003755 - IG/1424/G


Please note that the size of the above document can exceed 50 pages.

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Pharmacotherapeutic group

Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids

Therapeutic indication

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

Assessment history

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