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.
Therapeutic Indication
### Therapeutic indication Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Therapeutic Area (MeSH)
ATC Code
R03AL04
ATC Item
indacaterol and glycopyrronium bromide
Pharmacotherapeutic Group
Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
Active Substance (Summary)
INN / Common Names
EMA Name
Xoterna Breezhaler
Medicine Name
Xoterna Breezhaler
Aliases
N/A