BroPair Spiromax
Withdrawn
salmeterol / fluticasone propionate
Medicine
Human
Withdrawn
On 23 May 2025, the European Commission withdrew the marketing authorisation for BroPair Spiromax (salmeterol / fluticasone propionate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
BroPair Spiromax was granted marketing authorisation in the EU on 26 March 2021 for the treatment of asthma. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2024.
BroPair Spiromax was a duplicate application to Seffalair Spiromax, which is authorised in the EU to treat asthma and is marketed in several EU countries.
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Product information documents contain:
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.