salmeterol xinafoate / fluticasone propionate
Table of contents
The marketing authorisation for Airexar Spiromax has been withdrawn at the request of the marketing-authorisation holder.
Airexar Spiromax : EPAR - Summary for the public (PDF/238.39 KB)
First published: 05/09/2016
Last updated: 05/09/2016
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
19/02/2018 Airexar Spiromax - EMEA/H/C/004267 - IAIN/0003
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Drugs for obstructive airway diseases
Airexar Spiromax is indicated for use in adults aged 18 years and older only.
Airexar 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
- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.
Chronic Obstructive Pulmonary Disease (COPD)Airexar 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.