DuoResp Spiromax

budesonide / formoterol

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

: 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.

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DuoResp Spiromax : EPAR - Summary for the public (PDF/77.99 KB)

First published: 20/05/2014
Last updated: 20/05/2014
EMA/121020/2014
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DuoResp Spiromax : EPAR - Risk-management-plan summary (PDF/70.41 KB)

First published: 20/05/2014
Last updated: 20/05/2014

More detail is available in the summary of product characteristics

This EPAR was last updated on 07/05/2019

Authorisation details

Product details
Name	DuoResp Spiromax
Agency product number	EMEA/H/C/002348
Active substance	budesonide formoterol fumarate dihydrate
International non-proprietary name (INN) or common name	budesonide / formoterol
Therapeutic area (MeSH)	Pulmonary Disease, Chronic Obstructive Asthma
Anatomical therapeutic chemical (ATC) code	R03AK07

Publication details
Marketing-authorisation holder	Teva Pharma B.V.
Revision	7
Date of issue of marketing authorisation valid throughout the European Union	28/04/2014
Contact address	Computerweg 10 3542 DR Utrecht The Netherlands

Product information

08/04/2019 DuoResp Spiromax - EMEA/H/C/002348 - R/0027

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DuoResp Spiromax : EPAR - Product Information (PDF/841.43 KB)

First published: 20/05/2014
Last updated: 07/05/2019
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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.

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DuoResp Spiromax : EPAR - All Authorised presentations (PDF/26.73 KB)

First published: 20/05/2014
Last updated: 20/05/2014
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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

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DuoResp Spiromax : EPAR - Procedural steps taken and scientific information after authorisation (PDF/107.67 KB)

First published: 02/10/2014
Last updated: 07/05/2019
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DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Scientific Conclusion (PDF/39.48 KB)

First published: 18/07/2016
Last updated: 18/07/2016
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DuoResp Spiromax-H-C-2348-A31-1415 : EPAR - Assessment Report - Article-31 (PDF/228.27 KB)

Adopted

First published: 18/07/2016
Last updated: 18/07/2016
EMA/330021/2016

DuoResp Spiromax

Table of contents

Overview