Bretaris Genuair

aclidinium bromide

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This is a summary of the European public assessment report (EPAR) for Bretaris Genuair. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bretaris Genuair.

What is Bretaris Genuair?

Bretaris Genuair is a medicine that contains the active substance aclidinium bromide. It is available as an inhalation powder in a portable inhaler device. The inhaler delivers 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium for each inhalation.

What is Bretaris Genuair used for?

Bretaris Genuair 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.

The medicine can only be obtained with a prescription.

How is Bretaris Genuair used?

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

How does Bretaris Genuair work?

The active substance in Bretaris Genuair, aclidinium bromide, is an anticholinergic bronchodilator. This means that it widens the airways by blocking some receptors in muscle cells in the lungs called muscarinic receptors, which control the contraction of muscles. When aclidinium bromide is inhaled, it causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

How has Bretaris Genuair been studied?

The effects of Bretaris Genuair were first tested in experimental models before being studied in humans.

In the main study involving 828 patients with COPD, two different doses of Bretaris Genuair (200 and 400 micrograms) given twice a day were compared with placebo (a dummy treatment). 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) after six months.

What benefit has Bretaris Genuair shown during the studies?

Bretaris Genuair was more effective than placebo at improving how well the lungs work in patients with COPD. On average, after six months of treatment the increase in FEV1 in patients who received 200 and 400 micrograms Bretaris Genuair was 99 ml and 128 ml compared with placebo, respectively. 400 micrograms of Bretaris Genuair corresponds to the amount of aclidinium bromide contained in the inhaler which delivers 322 micrograms of aclidinium.

What is the risk associated with Bretaris Genuair?

The most common side effects with Bretaris Genuair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough and diarrhoea. For the full list of all side effects reported with Bretaris Genuair, see the package leaflet.

Bretaris Genuair must not be used in people who are hypersensitive (allergic) to aclidinium bromide, atropine, other related anticholinergic bronchodilator medicines, or any of the other ingredients.

Why has Bretaris Genuair been approved?

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 anticholinergic bronchodilator medicines. Therefore, the CHMP decided that Bretaris Genuair’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Bretaris Genuair?

As anticholinergic 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.

Other information about Bretaris Genuair

The European Commission granted a marketing authorisation valid throughout the European Union for Bretaris Genuair on 24 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.

Name Language First published Last updated
Bretaris Genuair : EPAR - Summary for the public BG = bălgarski 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public ES = español 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public CS = čeština 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public DA = dansk 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public DE = Deutsch 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public ET = eesti keel 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public EL = elliniká 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public EN = English 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public FR = français 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public IT = italiano 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public LV = latviešu valoda 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public LT = lietuvių kalba 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public HU = magyar 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public MT = Malti 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public NL = Nederlands 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public PL = polski 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public PT = português 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public RO = română 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public SK = slovenčina 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public SL = slovenščina 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public FI = suomi 19/09/2012 09/08/2013
Bretaris Genuair : EPAR - Summary for the public SV = svenska 19/09/2012 09/08/2013

This EPAR was last updated on 05/11/2015 .

Authorisation details

Product details

Product details for Bretaris Genuair
NameBretaris Genuair
Agency product numberEMEA/H/C/002706
Active substance

aclidinium bromide, micronised

International non-proprietary name (INN) or common name

aclidinium bromide

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03BB
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Bretaris Genuair
Marketing-authorisation holder

AstraZeneca AB

Revision10
Date of issue of marketing authorisation valid throughout the European Union20/07/2012

Contact address:

AstraZeneca AB
Gartunavagen
SE-15185 Sodertalje
Sewden

Product information

Product information

13/10/2015  Bretaris Genuair -EMEA/H/C/002706 -N/0022

Name Language First published Last updated
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015
Bretaris Genuair : EPAR - Product Information SV = svenska 19/09/2012 05/11/2015

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
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  
Bretaris Genuair : EPAR - All Authorised presentations SV = svenska 19/09/2012  

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).

Assessment History

Authorised

This medicine is approved for use in the European Union