Enurev Breezhaler

glycopyrronium bromide

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This is a summary of the European public assessment report (EPAR) for Enurev Breezhaler. 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 Enurev Breezhaler.

What is Enurev Breezhaler?

Enurev Breezhaler is a medicine that contains the active substance glycopyrronium bromide. It is available as capsules containing a powder for inhalation.

What is Enurev Breezhaler used for?

Enurev Breezhaler 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. Enurev Breezhaler is used for maintenance (regular) treatment.

The medicine can only be obtained with a prescription.

How is Enurev Breezhaler used?

Enurev Breezhaler capsules are only used with the Enurev Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes the powder contained in the capsule in through the mouth. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

The recommended dose is one capsule once a day at the same time each day. Patients should not take more than one capsule in a day.

How does Enurev Breezhaler work?

Enurev Breezhaler 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 the active substance in Enurev Breezhaler, glycopyrronium 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 Enurev Breezhaler been studied?

The effects of Enurev Breezhaler were first tested in experimental models before being studied in humans.

Enurev Breezhaler has been studied in two main studies involving a total of 1,888 patients with COPD, where Enurev Breezhaler was compared with placebo (a dummy treatment). In both studies, the main measure of effectiveness was how Enurev Breezhaler improved patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks of treatment.

What benefit has Enurev Breezhaler shown during the studies?

Enurev Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD: after 12 weeks of treatment, the increase in FEV1 with Enurev Breezhaler was 97 ml more than with placebo in the first study and 108 ml more in the second study.

What is the risk associated with Enurev Breezhaler?

The most common side effects with Enurev Breezhaler (seen in between 1 and 10 patients in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping) and gastroenteritis (diarrhoea and vomiting). For the full list of all side effects reported with Enurev Breezhaler, see the package leaflet.

Enurev Breezhaler must not be used in people who are hypersensitive (allergic) to glycopyrronium bromide or any of the other ingredients.

Why has Enurev Breezhaler been approved?

The CHMP noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and was also seen to improve the symptoms of COPD. The CHMP also noted that the fact that the medicine is used once a day may help patients to comply with their treatment. In addition, there were no major safety concerns with Enurev Breezhaler, with side effects being similar to other anticholinergic bronchodilator medicines. Therefore, the CHMP decided that Enurev 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 use of Enurev Breezhaler?

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

Other information about Enurev Breezhaler

The European Commission granted a marketing authorisation valid throughout the European Union for Enurev Breezhaler on 28 September 2012.

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

Name Language First published Last updated
Enurev Breezhaler : EPAR - Summary for the public BG = bălgarski 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public ES = español 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public CS = čeština 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public DA = dansk 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public DE = Deutsch 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public ET = eesti keel 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public EL = elliniká 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public EN = English 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public FR = français 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public IT = italiano 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public LV = latviešu valoda 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public LT = lietuvių kalba 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public HU = magyar 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public MT = Malti 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public NL = Nederlands 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public PL = polski 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public PT = português 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public RO = română 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public SK = slovenčina 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public SL = slovenščina 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public FI = suomi 17/10/2012  
Enurev Breezhaler : EPAR - Summary for the public SV = svenska 17/10/2012  

This EPAR was last updated on 28/09/2015 .

Authorisation details

Product details

Product details for Enurev Breezhaler
NameEnurev Breezhaler
Agency product numberEMEA/H/C/002691
Active substance

glycopyrronium bromide

International non-proprietary name (INN) or common name

glycopyrronium bromide

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03BB06
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 Enurev Breezhaler
Marketing-authorisation holder

Novartis Europharm Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union28/09/2012

Contact address:

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

Product information

Product information

30/07/2015  Enurev Breezhaler -EMEA/H/C/002691 -WS/0782

Name Language First published Last updated
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015
Enurev Breezhaler : EPAR - Product Information SV = svenska 17/10/2012 28/09/2015

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
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015
Enurev Breezhaler : EPAR - All Authorised presentations SV = svenska 17/10/2012 08/06/2015

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Enurev Breezhaler : EPAR - Public assessment report SV = svenska 17/10/2012  
CHMP summary of positive opinion for Enurev Breezhaler SV = svenska 22/06/2012 07/08/2012

Authorised

This medicine is approved for use in the European Union