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Aerivio Spiromax (salmeterol;fluticasone propionate)

Region
🇪🇺 EU
Active substance
salmeterol;fluticasone propionate
Company
Teva B.V.
Status
Withdrawn
Therapeutic area
Pulmonary Disease, Chronic Obstructive; Asthma
CHMP opinion
Thu 23 Jun 2016
EU approval
Thu 18 Aug 2016
Application
EMEA/H/C/002752
ATC
R03AK06
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.