Onbrez Breezhaler

indacaterol

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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.

What is Onbrez Breezhaler and what is it used for?

Onbrez Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Onbrez Breezhaler is used for maintenance (regular) treatment.

The medicine contains the active substance indacaterol.

How is Onbrez Breezhaler used?

Onbrez Breezhaler capsules, which contain a power for inhalation, are only used with a Onbrez Breezhaler inhaler and must not be swallowed. To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.

The recommended dose is one 150 microgram capsule, once a day at the same time each day. The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.

The medicine can only be obtained with a prescription.

How does Onbrez Breezhaler work?

The active substance in Onbrez Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist. It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax. When Onbrez Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

What benefits of Onbrez Breezhaler have been shown in studies?

In three main studies involving over 4,000 patients with COPD, Onbrez Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD). The main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.

Onbrez Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD. On average, the increase in FEV1 in patients who received Onbrez Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml. Overall, the effects of the 150 and 300 microgram doses of Onbrez Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease. The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.

What are the risks associated with Onbrez Breezhaler?

The most common side effects with Onbrez Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat). Other common side effects include chest pain, cough and muscle cramps.

For the full list of all side effects and restrictions with Onbrez Breezhaler, see the package leaflet.

Why is Onbrez Breezhaler approved?

The European Medicines Agency concluded that Onbrez Breezhaler was shown to be effective at improving the lung function in COPD. The Agency also noted that there were no major safety concerns with Onbrez Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines. Therefore, the Agency decided that Onbrez Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Onbrez Breezhaler?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onbrez Breezhaler have been included in the summary of product characteristics and the package leaflet.

Other information about Onbrez Breezhaler

European Commission granted a marketing authorisation valid throughout the European Union for Onbrez Breezhaler on 30 November 2009.

For more information about treatment with Onbrez Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Onbrez Breezhaler : EPAR - Summary for the public BG = bălgarski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public ES = español 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public CS = čeština 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public DA = dansk 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public DE = Deutsch 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public ET = eesti keel 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public EL = elliniká 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public EN = English 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public FR = français 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public IT = italiano 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public LV = latviešu valoda 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public LT = lietuvių kalba 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public HU = magyar 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public MT = Malti 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public NL = Nederlands 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public PL = polski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public PT = português 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public RO = română 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public SK = slovenčina 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public SL = slovenščina 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public FI = suomi 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public SV = svenska 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Summary for the public HR = Hrvatski 2010-01-05 2017-10-12

This EPAR was last updated on 12/10/2017 .

Authorisation details

Product details

Product details for Onbrez Breezhaler
NameOnbrez Breezhaler
Agency product numberEMEA/H/C/001114
Active substance

indacaterol maleate

International non-proprietary name (INN) or common name

indacaterol

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AC18

Publication details

Publication details for Onbrez Breezhaler
Marketing-authorisation holder

Novartis Europharm Ltd.
 

Revision10
Date of issue of marketing authorisation valid throughout the European Union30/11/2009

Contact address:

Novartis Europharm Ltd.
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

Product information

26/09/2017  Onbrez Breezhaler -EMEA/H/C/001114 -PSUSA/00001730/201611

Name Language First published Last updated
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12
Onbrez Breezhaler : EPAR - Product Information HR = Hrvatski 2010-01-05 2017-10-12

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.


Name Language First published Last updated
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  
Onbrez Breezhaler : EPAR - All Authorised presentations HR = Hrvatski 2010-01-05  

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

Authorised

This medicine is approved for use in the European Union