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Airexar Spiromax (salmeterol xinafoate;fluticasone propionate)

Region

🇪🇺 EU

Active substance

salmeterol xinafoate;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Withdrawn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/004267

ATC

R03AK06

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

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.