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EMA Product

DuoResp Spiromax

Product approved by European Medicines Agency (EU)

Basic Information

DuoResp Spiromax

Regulatory Information

EMEA/H/C/002348

Authorised

April 28, 2014

13

July 24, 2024

Company Information

the netherlands

Computerweg 10 3542 DR Utrecht

Teva Pharma B.V.

Active Substances Detail

Budesonideformoterol fumarate dihydrate

Detailed Information

Therapeutic Indication

### Therapeutic indication **Asthma** DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate: - in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists. or - in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists. **COPD** DuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Overview Summary

DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ (such as budesonide and formoterol) taken by inhalation. DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing. DuoResp Spiromax is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but DuoResp Spiromax is given using a different inhaler. The reference medicine for DuoResp Spiromax is Symbicort Turbohaler.

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