Xoterna Breezhaler

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indacaterol / glycopyrronium bromide

Authorised
This medicine is authorised for use in the European Union.

Overview

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 12/11/2018

Authorisation details

Product details
Name
Xoterna Breezhaler
Agency product number
EMEA/H/C/003755
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
R03AL04
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
18/09/2013
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

10/10/2018 Xoterna Breezhaler - EMEA/H/C/003755 - N/0032

Contents

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

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