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🇪🇺EU · EMAWithdrawnATC: R03AK06

Airexar Spiromax(salmeterol;fluticasone propionate)

Pulmonary Disease, Chronic Obstructive;Asthma

Marketing Authorisation Holder: Teva B.V.

EMA Authorisation: 18/08/2016

INN: salmeterol xinafoate;fluticasone propionate

Indication

Airexar Spiromax is indicated for use in adults aged 18 years and older only. AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting ?2 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 ?2 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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.