Incruse

umeclidinium bromide

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

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

What is Incruse and what is it used for?

Incruse is a medicine that contains the active substance umeclidinium bromide. 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. Incruse is used for maintenance (regular) treatment.

How is Incruse used?

Incruse can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device. The inhaler delivers 65 micrograms of umeclidinium bromide equivalent to 55 micrograms of umeclidinium for 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 Incruse work?

The active substance in Incruse, umeclidinium bromide, is a muscarinic receptor antagonist. It works by blocking some receptors called muscarinic receptors, which control the contraction of muscles. When umeclidinium 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.

What benefits of Incruse have been shown in studies?

Incruse was investigated in four main studies involving over 4,000 patients. Three studies compared Incruse with placebo (a dummy treatment), while one study compared Incruse with tiotropium (another medicine for COPD). 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 Incruse at a dose of equivalent to 55 micrograms of umeclidinium improved lung function by an average FEV1 by 127 ml more than placebo after 12 weeks of treatment and by 115 ml after 24 weeks of treatment. Incruse given at double that dose only showed small improvements compared with the lower dose, which were not considered relevant. In the study comparing Incruse with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.

The studies also showed an improvement in symptoms such as breathlessness and wheezing.

What are the risks associated with Incruse?

The most common side effects with Incruse (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (cold), sinusitis, cough, urinary tract infection, and tachycardia (increased heart rate).

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

Why is Incruse approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Incruse’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Incruse was shown to be effective at improving the lung function and symptoms of COPD. The CHMP also noted that there were no major safety concerns with Incruse, with side effects being manageable and similar to other antimuscarinic bronchodilator medicines.

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

A risk management plan has been developed to ensure that Incruse 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 Incruse, including the appropriate precautions to be followed by healthcare professionals and patients.

As antimuscarinic 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.

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

Other information about Incruse

The European Commission granted a marketing authorisation valid throughout the European Union for Incruse on 28 April 2014.

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

Name Language First published Last updated
Incruse : EPAR - Summary for the public BG = bălgarski 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public ES = español 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public CS = čeština 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public DA = dansk 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public DE = Deutsch 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public ET = eesti keel 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public EL = elliniká 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public EN = English 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public FR = français 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public IT = italiano 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public LV = latviešu valoda 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public LT = lietuvių kalba 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public HU = magyar 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public MT = Malti 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public NL = Nederlands 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public PL = polski 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public PT = português 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public RO = română 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public SK = slovenčina 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public SL = slovenščina 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public FI = suomi 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public SV = svenska 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public HR = Hrvatski 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public IS = Islenska 22/05/2014 13/02/2015
Incruse : EPAR - Summary for the public NO = Norsk 22/05/2014 13/02/2015
Name Language First published Last updated
Incruse : EPAR - Risk-management-plan summary (English only) 22/05/2014  

This EPAR was last updated on 21/12/2015 .

Authorisation details

Product details

Product details for Incruse
NameIncruse
Agency product numberEMEA/H/C/002809
Active substance

umeclidinium bromide

International non-proprietary name (INN) or common name

umeclidinium bromide

Therapeutic area Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03BB07
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 Incruse
Marketing-authorisation holder

Glaxo Group Ltd

Revision3
Date of issue of marketing authorisation valid throughout the European Union28/04/2014

Contact address:

Glaxo Group Ltd
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

Product information

Product information

30/09/2015  Incruse -EMEA/H/C/002809 -IB/0006

Name Language First published Last updated
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015
Incruse : EPAR - Product Information EN = English 22/05/2014 21/12/2015

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
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  
Incruse : EPAR - All Authorised presentations EN = English 22/05/2014  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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

Name Language First published Last updated
Incruse : EPAR - Procedural steps taken and scientific information after authorisation EN = English 13/02/2015 21/12/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Incruse : EPAR - Public assessment report EN = English 22/05/2014  
CHMP summary of positive opinion for Incruse EN = English 21/02/2014  

Authorised

This medicine is approved for use in the European Union