This is a summary of the European public assessment report (EPAR) for Eklira 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 Eklira Genuair.
- What is Eklira Genuair?
Eklira 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 Eklira Genuair used for?
Eklira 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. Eklira Genuair is used for maintenance (regular) treatment.
The medicine can only be obtained with a prescription.
- How is Eklira Genuair used?
The recommended dose of Eklira 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 Eklira Genuair work?
The active substance in Eklira 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 Eklira Genuair been studied?
The effects of Eklira 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 Eklira Genuair (200 and 400 micrograms) given twice a day were compared with placebo (a dummy treatment). The main measure of effectiveness was how Eklira 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 Eklira Genuair shown during the studies?
Eklira 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 Eklira Genuair was 99 ml and 128 ml compared with placebo, respectively. 400 micrograms of Eklira Genuair corresponds to the amount of aclidinium bromide contained in the inhaler which delivers 322 micrograms of aclidinium.
- What is the risk associated with Eklira Genuair?
The most common side effects with Eklira 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 Eklira Genuair, see the package leaflet.
Eklira 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 Eklira Genuair been approved?
The CHMP noted that Eklira 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 Eklira Genuair, with side effects being reversible and similar to other anticholinergic bronchodilator medicines. Therefore, the CHMP decided that Eklira 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 Eklira 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 Eklira Genuair
The European Commission granted a marketing authorisation valid throughout the European Union for Eklira Genuair on 20 July 2012.
For more information about treatment with Eklira Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 11/11/2016 .
15/09/2016 Eklira Genuair -EMEA/H/C/002211 -PSUSA/9005
- 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.
Drugs for obstructive airway diseases
Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Eklira Genuair : EPAR - Procedural steps taken and scientific information after authorisation||SV = svenska||2013-01-24||2016-11-11|
|Eklira Genuair-H-C-2211-PSUSA-9005-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation||SV = svenska||2015-06-03|
|Eklira Genuair-H-C-2211-PSUV-0008: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation||SV = svenska||2014-07-23|
|Eklira Genuair-H-C-2211-PSUV-0007 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation||SV = svenska||2013-11-25|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Eklira Genuair : EPAR - Public assessment report||SV = svenska||2012-09-19|
|CHMP positive summary of opinion for Eklira Genuair||SV = svenska||2012-05-25||2012-06-28|
This medicine is approved for use in the European Union