indacaterol / glycopyrronium bromide
This is a summary of the European public assessment report (EPAR) for Ultibro 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 Ultibro Breezhaler.
For practical information about using Ultibro Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Ultibro Breezhaler : EPAR - Summary for the public (PDF/84.08 KB)
First published: 03/10/2013
Last updated: 03/10/2013
Ultibro Breezhaler : EPAR - Risk-management-plan summary (PDF/121.8 KB)
First published: 02/05/2018
Last updated: 20/08/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Pulmonary Disease, Chronic Obstructive
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
12/11/2020 Ultibro Breezhaler - EMEA/H/C/002679 - WS/1932
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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.
Adrenergics in combinations with anticholinergics incl. triple combinations with corticosteroids
Drugs for obstructive airway diseases
Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).