BroPair Spiromax
Withdrawn
This medicine's authorisation has been withdrawn
salmeterol / fluticasone propionate
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Product information
Latest procedure affecting product information:N/0000258678
01/04/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- BroPair Spiromax
- Active substance
- salmeterol xinafoate
- fluticasone propionate
- International non-proprietary name (INN) or common name
- salmeterol
- fluticasone propionate
- Therapeutic area (MeSH)
- Asthma
- Anatomical therapeutic chemical (ATC) code
- R03AK06
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic 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.
News on BroPair Spiromax
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