Onbrez Breezhaler

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indacaterol

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Onbrez 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 Onbrez Breezhaler.

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

This EPAR was last updated on 31/08/2018

Authorisation details

Product details
Name
Onbrez Breezhaler
Agency product number
EMEA/H/C/001114
Active substance
indacaterol maleate
International non-proprietary name (INN) or common name
indacaterol
Therapeutic area (MeSH)
Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AC18
Publication details
Marketing-authorisation holder
Novartis Europharm Limited 
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
29/11/2009
Contact address

Elm Park
Vista Building
Merrion Road
Dublin 4
Ireland

Product information

23/08/2018 Onbrez Breezhaler - EMEA/H/C/001114 - IA/0050

Contents

  • 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.

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Assessment history

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