salmeterol / fluticasone propionate
Aerivio Spiromax : EPAR - Summary for the public
First published: 02/09/2016
Last updated: 15/01/2020
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04/10/2019 Aerivio Spiromax - EMEA/H/C/002752 - 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
Aerivio Spiromax is indicated for use in adults aged 18 years and older only.
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.