Vylaer Spiromax

budesonide / formoterol

  • Email
  • Help

About

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

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

What is Vylaer Spiromax and what is it used for?

Vylaer Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used for the treatment of asthma in adults for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ taken by inhalation.

Vylaer Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.

Vylaer Spiromax is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but Vylaer Spiromax is given using a different inhaler. The reference medicine for Vylaer Spiromax is Symbicort Turbohaler.

How is Vylaer Spiromax used?

The medicine can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine. Vylaer Spiromax 160/4.5 microgram can be used for the regular treatment of asthma. It can also be used for the treatment of COPD.

For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma. For asthma reliever therapy, patients should take a separate ‘reliever inhaler’ to relieve their symptoms. If patients need to take more than 8 reliever inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.

For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.

For further information, see the package leaflet.

How does Vylaer Spiromax work?

The two active substances in Vylaer Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.

Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.

Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When inhaled it mainly attaches to the receptors in the airways and causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.

What are the benefits and risks of Vylaer Spiromax?

Studies were carried out to show that Vylaer Spiromax is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way. The benefits and risks of Vylaer Spiromax are therefore taken to be the same as those of the reference medicine.

Why is Vylaer Spiromax approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler. Therefore, the CHMP’s view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk. The Committee recommended that Vylaer Spiromax be given marketing authorisation.

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

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

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

Other information about Vylaer Spiromax

The European Commission granted a marketing authorisation valid throughout the European Union for Vylaer Spiromax on 19 November 2014.

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

Name Language First published Last updated
Vylaer Spiromax : EPAR - Summary for the public BG = bălgarski 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public ES = español 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public CS = čeština 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public DA = dansk 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public DE = Deutsch 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public ET = eesti keel 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public EL = elliniká 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public EN = English 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public FR = français 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public IT = italiano 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public LV = latviešu valoda 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public LT = lietuvių kalba 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public HU = magyar 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public MT = Malti 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public NL = Nederlands 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public PL = polski 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public PT = português 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public RO = română 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public SK = slovenčina 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public SL = slovenščina 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public FI = suomi 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public SV = svenska 05/12/2014  
Vylaer Spiromax : EPAR - Summary for the public HR = Hrvatski 05/12/2014  
Name Language First published Last updated
Vylaer Spiromax : EPAR - Risk-management-plan summary (English only) 05/12/2014  

This EPAR was last updated on 14/10/2015 .

Authorisation details

Product details

Product details for Vylaer Spiromax
NameVylaer Spiromax
Agency product numberEMEA/H/C/003952
Active substance

budesonide / formoterol fumarate dihydrate

International non-proprietary name (INN) or common name

budesonide / formoterol

Therapeutic area AsthmaPulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AK07

Publication details

Publication details for Vylaer Spiromax
Marketing-authorisation holder

Teva Pharma B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/11/2014

Contact address:

Teva Pharma B.V.
Computerweg 10
3542DR Utrecht
The Netherlands

Product information

Product information

17/09/2015  Vylaer Spiromax -EMEA/H/C/003952 -IB/0006/G

Name Language First published Last updated
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015
Vylaer Spiromax : EPAR - Product Information EN = English 05/12/2014 14/10/2015

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
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015
Vylaer Spiromax : EPAR - All Authorised presentations EN = English 05/12/2014 10/03/2015

Pharmacotherapeutic group

Inhalation powder

Therapeutic indication

Vylaer Spiromax is indicated in adults 18 years of age and older only.

Asthma
Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:

  • in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
    or
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

COPD
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Vylaer Spiromax : EPAR - Procedural steps taken and scientific information after authorisation EN = English 10/03/2015 14/10/2015

Initial marketing-authorisation documents

Name Language First published Last updated
Vylaer Spiromax : EPAR - Public assessment report EN = English 05/12/2014  
CHMP summary of positive opinion for Vylaer Spiromax EN = English 26/09/2014