Bretaris Genuair（阿地溴铵）EPAR 评估报告更新：COPD 维持治疗，欧盟已授权

Application under evaluation
CHMP opinion
European Commission decision

Overview

Introduction

This is a summary of the European public assessment report (EPAR) for Bretaris Genuair. 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 Bretaris Genuair.

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

Bretaris Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Bretaris Genuair is used for maintenance (regular) treatment.

Bretaris Genuair contains the active substance aclidinium bromide.

Bretaris Genuair is available as an inhalation powder in a portable inhaler device. Each inhalation provides 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium.

The recommended dose of Bretaris Genuair is one inhalation twice a day. For detailed information on using the inhaler correctly, see the instructions in the package leaflet.

Bretaris Genuair can only be obtained with a prescription.

The active substance in Bretaris Genuair, aclidinium bromide, is an antimuscarinic bronchodilator. This means that it widens the airways by blocking muscarinic receptors. Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.

A main study involving 828 patients with COPD found that Bretaris Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work. The study compared two doses of Bretaris Genuair (200 and 400 micrograms) inhaled twice a day with placebo. The main measure of effectiveness was how Bretaris Genuair improved patients’ forced expiratory volumes (FEV₁, the maximum volume of air a person can breathe out in one second). On average, after six months of treatment, the FEV₁ in patients who used 200 and 400 micrograms Bretaris Genuair increased compared with placebo by 99 ml and 128 ml respectively. The dose of 400 micrograms Bretaris Genuair corresponds to an inhalation providing 322 micrograms of aclidinium.

The most common side effects with Bretaris Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat). Other common side effects (which may affect more than 1 patient in 100) are sinusitis (inflammation of the sinuses), cough, nausea (feeling sick) and diarrhoea. For the full list of all side effects and restrictions with Bretaris Genuair, see the package leaflet.

The CHMP noted that Bretaris Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year. The CHMP also noted that there were no major safety concerns with Bretaris Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines. Therefore, the CHMP decided that Bretaris Genuair’s benefits are greater than its risks and recommended that it be given marketing authorisation.

As antimuscarinic bronchodilator medicines may have an effect on the heart and blood vessels, the company will closely monitor the medicine’s cardiovascular effects and will carry out a further study in patients to identify any potential risks.

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

The European Commission granted a marketing authorisation valid throughout the European Union for Bretaris Genuair on 20 July 2012.

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

Product information

Latest procedure affecting product information:T/0000370307

16/10/2026

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This medicine’s product information is available in all official EU languages.
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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: Bretaris Genuair
Active substance: aclidinium bromide
International non-proprietary name (INN) or common name: aclidinium bromide
Therapeutic area (MeSH): Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code: R03BB

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

EMA product number

EMEA/H/C/002706

Marketing authorisation holder

Azurity Pharmaceuticals Ireland Ltd.

The Observatory
7-11 Sir John Rogerson’s Quay
Dublin 2, D02 VC42
Ireland

Marketing authorisation issued

20/07/2012

Revision

This page was last updated on 27/10/2026