Aerivio Spiromax

salmeterol / fluticasone propionate

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

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

What is Aerivio Spiromax and what is it used for?

Aerivio Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing). It contains the active substances salmeterol (a so-called long-acting beta-2 agonist) and fluticasone propionate (a corticosteroid).

In asthma, Aerivio Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled corticosteroid.

In COPD, Aerivio Spiromax is used in adults who have had exacerbations (flare–ups) of the disease in the past and have significant symptoms despite regular treatment.

Aerivio Spiromax is a ‘hybrid medicine’. This means that Aerivio Spiromax is similar to a ‘reference medicine’ called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances. However, Aerivio Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths. As Aerivio Spiromax is only available in one high strength, its use in asthma has been restricted to patients whose disease is severe.

How is Aerivio Spiromax used?

Aerivio Spiromax is available as an inhalation powder in a portable inhaler device. Each inhalation provides a fixed dose of the medicine.

The recommended dose is one inhalation twice a day. Patients should be regularly assessed by a doctor to ensure that they receive the lowest dose sufficient to control symptoms. Since Aerivio Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower dose of fluticasone propionate.

Aerivio Spiromax can only be obtained with a prescription. For further information, see the package leaflet.

How does Aerivio Spiromax work?

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

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

Fluticasone propionate 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.

How has Aerivio Spiromax been studied?

Studies in people have been limited to tests to determine that Aerivio Spiromax is bioequivalent to the reference medicine, Seretide Diskus. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What are the benefits and risks of Aerivio Spiromax?

Because Aerivio 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 Aerivio Spiromax approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus. Therefore, the CHMP’s view was that, as for Seretide Diskus, the benefit outweighs the identified risk. The Committee recommended that Aerivio Spiromax be approved for use in the EU.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aerivio Spiromax have been included in the summary of product characteristics and the package leaflet.

Other information about Aerivio Spiromax

The European Commission granted a marketing authorisation valid throughout the European Union for Aerivio Spiromax on 18 August 2016.

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

Name Language First published Last updated
Aerivio Spiromax : EPAR - Summary for the public BG = bălgarski 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public ES = español 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public CS = čeština 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public DA = dansk 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public DE = Deutsch 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public ET = eesti keel 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public EL = elliniká 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public EN = English 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public FR = français 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public IT = italiano 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public LV = latviešu valoda 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public LT = lietuvių kalba 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public HU = magyar 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public MT = Malti 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public NL = Nederlands 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public PL = polski 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public PT = português 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public RO = română 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public SK = slovenčina 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public SL = slovenščina 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public FI = suomi 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public SV = svenska 2016-09-02  
Aerivio Spiromax : EPAR - Summary for the public HR = Hrvatski 2016-09-02  

This EPAR was last updated on 17/10/2017 .

Authorisation details

Product details

Product details for Aerivio Spiromax
NameAerivio Spiromax
Agency product numberEMEA/H/C/002752
Active substance

salmeterol xinafoate / fluticasone propionate

International non-proprietary name (INN) or common name

salmeterol / fluticasone propionate

Therapeutic area AsthmaPulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code R03AK06

Publication details

Publication details for Aerivio Spiromax
Marketing-authorisation holder

Teva B.V.

Revision2
Date of issue of marketing authorisation valid throughout the European Union18/08/2016

Contact address:

Teva B.V.
Swensweg 5 
2031GA Haarlem
The Netherlands

Product information

Product information

09/06/2017  Aerivio Spiromax -EMEA/H/C/002752 -IAIN/0003

Name Language First published Last updated
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17
Aerivio Spiromax : EPAR - Product Information HR = Hrvatski 2016-09-02 2017-10-17

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
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  
Aerivio Spiromax : EPAR - All Authorised presentations HR = Hrvatski 2016-09-02  

Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Aerivio Spiromax is indicated for use in adults aged 18 years and older only.

Asthma

Aerivio Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:

  • patients not adequately controlled on a lower strength corticosteroid combination product or
  • patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.

Chronic Obstructive Pulmonary Disease (COPD)

Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Aerivio Spiromax : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-04-10 2017-10-17

Initial marketing-authorisation documents

Name Language First published Last updated
Aerivio Spiromax : EPAR - Public assessment report HR = Hrvatski 2016-09-02  
CHMP summary of opinion for Aerivio Spiromax HR = Hrvatski 2016-06-24  

Authorised

This medicine is approved for use in the European Union