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 01/09/2021

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
13
Date of issue of marketing authorisation valid throughout the European Union
19/09/2013
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

06/08/2021 Ultibro Breezhaler - EMEA/H/C/002679 - IG/1424/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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