Laventair

umeclidinium bromide / vilanterol

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

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

What is Laventair and what is it used for?

Laventair is a medicine that contains the active substances umeclidinium bromide and vilanterol. It 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. Laventair is used for maintenance (regular) treatment.

How is Laventair used?

Laventair can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device. The inhaler delivers 22 micrograms of vilanterol and 65 micrograms of umeclidinium bromide (equivalent to 55 micrograms of umeclidinium) with each inhalation.

The recommended dose is one inhalation per day at the same time each day. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

How does Laventair work?

Laventair contains two active substances. Vilanterol is a long-acting beta-2 agonist. It works by attaching to beta-2 receptors found in the muscle cells of many organs including the airways in the lungs. When inhaled, vilanterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax.

Umeclidinium bromide is a muscarinic receptor antagonist. It works by blocking other receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium bromide is inhaled, it also causes the muscles of the airways to relax.

The combined action of the two active substances helps to keep the airways open and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2 agonists are commonly combined in the management of COPD.

What benefits of Laventair have been shown in studies?

The combination umeclidinium bromide and vilanterol was investigated in four main studies involving over 4,700 patients. Two studies compared two fixed-dose combinations of umeclidinium bromide and vilanterol (one corresponding to Laventair and one higher-dose combination) with vilanterol alone, umeclidinium bromide alone and placebo (a dummy treatment). Two other studies compared the same two fixed dose-combinations of umeclidinium bromide and vilanterol with another COPD medicine called tiotropium. 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).

Results showed that Laventair improved lung function by an average FEV1 of 167 ml more than placebo after 24 weeks of treatment. Laventair also increased FEV1 by an average of 95 ml more than vilanterol alone and by 52 ml more than umeclidinium bromide alone. The average increase in FEV1 with Laventair was 90 ml more than with tiotropium after 24 weeks of treatment. Laventair was also shown to improve symptoms such as breathlessness and wheezing.

The results for the higher dose combination of umeclidinium bromide and vilanterol did not consistently show relevant improvements in lung function.

What are the risks associated with Laventair?

The most common side effect with Laventair (seen in 9 patients in 100) is nasopharyngitis (inflammation of the nose and throat).

For the full list of all side effects and restrictions, see the package leaflet.

Why is Laventair approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Laventair’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Laventair was shown to be effective at improving lung function and the symptoms of COPD when compared with placebo or the single components as well as with tiotropium. The CHMP also noted that there were no major safety concerns with Laventair, with side effects being manageable, although the long-term safety data so far are limited.

What measures are being taken to ensure the safe and effective use of Laventair?

A risk management plan has been developed to ensure that Laventair is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Laventair, including the appropriate precautions to be followed by healthcare professionals and patients.

As medicines of the same class as Laventair may have an effect on the heart and blood vessels in the brain, the company will continue to closely monitor the medicine’s effects on the heart and brain and will carry out a further long-term study in patients to identify any potential risks.

Further information can be found in the summary of the risk management plan.

Other information about Laventair

The European Commission granted a marketing authorisation valid throughout the European Union for Laventair on 8 May 2014.

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

Name Language First published Last updated
Laventair : EPAR - Summary for the public BG = bălgarski 2014-06-13  
Laventair : EPAR - Summary for the public ES = español 2014-06-13  
Laventair : EPAR - Summary for the public CS = čeština 2014-06-13  
Laventair : EPAR - Summary for the public DA = dansk 2014-06-13  
Laventair : EPAR - Summary for the public DE = Deutsch 2014-06-13  
Laventair : EPAR - Summary for the public ET = eesti keel 2014-06-13  
Laventair : EPAR - Summary for the public EL = elliniká 2014-06-13  
Laventair : EPAR - Summary for the public EN = English 2014-06-13  
Laventair : EPAR - Summary for the public FR = français 2014-06-13  
Laventair : EPAR - Summary for the public IT = italiano 2014-06-13  
Laventair : EPAR - Summary for the public LV = latviešu valoda 2014-06-13  
Laventair : EPAR - Summary for the public LT = lietuvių kalba 2014-06-13  
Laventair : EPAR - Summary for the public HU = magyar 2014-06-13  
Laventair : EPAR - Summary for the public MT = Malti 2014-06-13  
Laventair : EPAR - Summary for the public NL = Nederlands 2014-06-13  
Laventair : EPAR - Summary for the public PL = polski 2014-06-13  
Laventair : EPAR - Summary for the public PT = português 2014-06-13  
Laventair : EPAR - Summary for the public RO = română 2014-06-13  
Laventair : EPAR - Summary for the public SK = slovenčina 2014-06-13  
Laventair : EPAR - Summary for the public SL = slovenščina 2014-06-13  
Laventair : EPAR - Summary for the public FI = suomi 2014-06-13  
Laventair : EPAR - Summary for the public SV = svenska 2014-06-13  
Laventair : EPAR - Summary for the public HR = Hrvatski 2014-06-13  
Name Language First published Last updated
Laventair : EPAR - Risk-management-plan summary (English only) 2014-06-13  

This EPAR was last updated on 22/11/2016 .

Authorisation details

Product details

Product details for Laventair
NameLaventair
Agency product numberEMEA/H/C/003754
Active substance

umeclidinium bromide / vilanterol

International non-proprietary name (INN) or common name

umeclidinium bromide / vilanterol

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AL03
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 Laventair
Marketing-authorisation holder

Glaxo Group Ltd

Revision5
Date of issue of marketing authorisation valid throughout the European Union08/05/2014

Contact address:

Glaxo Group Ltd
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex 
UB6 0NN
United Kingdom

Product information

Product information

18/10/2016  Laventair -EMEA/H/C/003754 -N/0016

Name Language First published Last updated
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22
Laventair : EPAR - Product Information EN = English 2014-06-13 2016-11-22

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
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  
Laventair : EPAR - All Authorised presentations EN = English 2014-06-13  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Laventair 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
Laventair : EPAR - Public assessment report EN = English 2014-06-13  
CHMP summary of positive opinion for Laventair EN = English 2014-02-21  

Authorised

This medicine is approved for use in the European Union