DuoResp Spiromax

budesonide / formoterol

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

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

What is DuoResp Spiromax and what is it used for?

DuoResp 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.

DuoResp 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.

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

How is DuoResp 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. DuoResp Spiromax 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever. It can also be used for the treatment of COPD. The higher strength, DuoResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and 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. As asthma reliever therapy, patients can take 1 or 2 additional inhalations of DuoResp Spiromax 160/4.5 microgram only to relieve their symptoms. If patients need to take more than 8 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 DuoResp Spiromax work?

The two active substances in DuoResp 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 it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.

How has DuoResp Spiromax been studied?

Studies in patients have been limited to tests to determine that DuoResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of DuoResp Spiromax?

Because DuoResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is DuoResp Spiromax approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that DuoResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent 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 DuoResp Spiromax be given marketing authorisation.

The company initially also applied for a lower strength of DuoResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.

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

A risk management plan has been developed to ensure that DuoResp 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 DuoResp 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 DuoResp Spiromax

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

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

Name Language First published Last updated
DuoResp Spiromax : EPAR - Summary for the public BG = bălgarski 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public ES = español 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public CS = čeština 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public DA = dansk 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public DE = Deutsch 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public ET = eesti keel 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public EL = elliniká 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public EN = English 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public FR = français 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public IT = italiano 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public LV = latviešu valoda 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public LT = lietuvių kalba 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public HU = magyar 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public MT = Malti 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public NL = Nederlands 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public PL = polski 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public PT = português 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public RO = română 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public SK = slovenčina 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public SL = slovenščina 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public FI = suomi 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public SV = svenska 2014-05-20  
DuoResp Spiromax : EPAR - Summary for the public HR = Hrvatski 2014-05-20  
Name Language First published Last updated
DuoResp Spiromax : EPAR - Risk-management-plan summary (English only) 2014-05-20  

This EPAR was last updated on 18/07/2016 .

Authorisation details

Product details

Product details for DuoResp Spiromax
NameDuoResp Spiromax
Agency product numberEMEA/H/C/002348
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 DuoResp Spiromax
Marketing-authorisation holder

Teva Pharma B.V.

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

Contact address:

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

Product information

Product information

04/07/2016  DuoResp Spiromax -EMEA/H/C/002348 -A31/0008

Name Language First published Last updated
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18
DuoResp Spiromax : EPAR - Product Information EN = English 2014-05-20 2016-07-18

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
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  
DuoResp Spiromax : EPAR - All Authorised presentations EN = English 2014-05-20  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

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

Asthma

DuoResp 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;
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

Chronic obstructive pulmonary disease

Symptomatic treatment of patients with severe chronic obstructive pulmonary disease - 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
DuoResp Spiromax : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2014-10-02 2016-07-18
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Assessment Report - Article-31 EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  
DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion EN = English 2016-07-18  

Initial marketing-authorisation documents

Name Language First published Last updated
DuoResp Spiromax : EPAR - Public assessment report EN = English 2014-05-20  
CHMP summary of positive opinion for DuoResp Spiromax EN = English 2014-02-21