Ulunar 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 Ulunar Breezhaler. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ulunar Breezhaler.

For practical information about using Ulunar Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 06/02/2020

Authorisation details

Product details
Ulunar Breezhaler
Agency product number
Active substance
  • Glycopyrronium bromide
  • indacaterol maleate
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

19/12/2019 Ulunar Breezhaler - EMEA/H/C/003875 - IG/1183


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

Drugs for obstructive airway diseases

Therapeutic indication

Ulunar 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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