Ultibro 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 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.

This EPAR was last updated on 28/01/2020

Authorisation details

Product details
Name
Ultibro Breezhaler
Agency product number
EMEA/H/C/002679
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
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
19/09/2013
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

19/12/2019 Ultibro Breezhaler - EMEA/H/C/002679 - IG/1183

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 combinations with anticholinergics incl. triple combinations with corticosteroids
  • Drugs for obstructive airway diseases

Therapeutic indication

Ultibro 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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