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EMA Product

BroPair Spiromax

Product approved by European Medicines Agency (EU)

Basic Information

BroPair Spiromax

Regulatory Information

EMEA/H/C/005591

Authorised

March 26, 2021

January 28, 2021

2

August 27, 2021

Company Information

the netherlands

Swensweg 5 2031GA Haarlem

Teva Pharma B.V.

Active Substances Detail

salmeterol xinafoatefluticasone propionate

Detailed Information

Therapeutic Indication

### Therapeutic indication BroPair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting ?? agonists.

Overview Summary

BroPair Spiromax is a medicine used for the regular treatment of asthma in adults and adolescents above 12 years of age. It is used in patients whose disease is not adequately controlled despite treatment with a combination of a short-acting beta-2 agonist and inhaled corticosteroid. It contains the active substances salmeterol and fluticasone.

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