- What is Aerivio Spiromax and what is it used for?
- How is Aerivio Spiromax used?
- How does Aerivio Spiromax work?
- How has Aerivio Spiromax been studied?
- What are the benefits and risks of Aerivio Spiromax?
- Why is Aerivio Spiromax approved?
- What measures are being taken to ensure the safe and effective use of Aerivio Spiromax?
salmeterol / fluticasone propionate
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
In asthma, Aerivio Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a
In COPD, Aerivio Spiromax is used in adults who have had exacerbations
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
Fluticasone propionate belongs to a group of
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.
The full EPAR for Aerivio Spiromax can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Aerivio Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in