Prognia
Drug Database
🇪🇺EU · EMAWithdrawnATC: R03AK06

Aerivio Spiromax(salmeterol xinafoate;fluticasone propionate)

Pulmonary Disease, Chronic Obstructive;Asthma

Marketing Authorisation Holder: Teva B.V.

EMA Authorisation: 18/08/2016

INN: salmeterol;fluticasone propionate

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 ?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) 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.

Official EMA Resources

View on EMA (ema.europa.eu)

AI Drug & Interaction Analysis

Free account required

Ask Prognia AI about Aerivio Spiromax — dosing recommendations, drug interactions, and current guideline evidence from ESC, EMA, NICE and more.

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