Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 03 August 2018

Indication(s)

BiResp Spiromax is indicated in adults 18 years of age and older only.

Asthma
BiResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
or
-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

COPD
Symptomatic treatment of patients with severe COPD (FEV1 < 70% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/003890
Orphan designation No
Date First Approved 28-04-2014
Type Medicinal product subject to medical prescription
Marketing authorisation holder Teva Pharma B.V.