Onbrez Breezhaler
Authorised
This medicine is authorised for use in the European Union
indacaterol
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
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.
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.
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.
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.
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information:
IG1807
21/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Onbrez Breezhaler
- 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
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.
Topics
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