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 02/08/2019

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

Elm Park, Merrion Road
Dublin 4

Product information

16/05/2019 Xoterna Breezhaler - EMEA/H/C/003755 - WS/1543


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.

Pharmacotherapeutic group

Adrenergics in combination with anticholinergic

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

How useful was this page?

Add your rating
1 rating
1 rating