BroPair Spiromax

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Withdrawn

This medicine's authorisation has been withdrawn

salmeterol / fluticasone propionate
Medicine Human Withdrawn
  • 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. 

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Product information

български (BG) (2.93 MB - PDF)

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español (ES) (2.37 MB - PDF)

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čeština (CS) (2.44 MB - PDF)

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dansk (DA) (2.25 MB - PDF)

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Deutsch (DE) (2.46 MB - PDF)

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eesti keel (ET) (2.26 MB - PDF)

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ελληνικά (EL) (3.22 MB - PDF)

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français (FR) (2.52 MB - PDF)

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hrvatski (HR) (2.53 MB - PDF)

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íslenska (IS) (2.2 MB - PDF)

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italiano (IT) (2.46 MB - PDF)

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latviešu valoda (LV) (2.69 MB - PDF)

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lietuvių kalba (LT) (2.59 MB - PDF)

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magyar (HU) (2.55 MB - PDF)

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Malti (MT) (2.86 MB - PDF)

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Nederlands (NL) (2.33 MB - PDF)

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norsk (NO) (2.23 MB - PDF)

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polski (PL) (2.88 MB - PDF)

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português (PT) (2.26 MB - PDF)

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română (RO) (2.83 MB - PDF)

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slovenčina (SK) (2.43 MB - PDF)

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slovenščina (SL) (2.48 MB - PDF)

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Suomi (FI) (2.4 MB - PDF)

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svenska (SV) (2.22 MB - PDF)

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Latest procedure affecting product information:N/0000258678
01/04/2025
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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).

български (BG) (121.33 KB - PDF)

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español (ES) (105.46 KB - PDF)

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čeština (CS) (112.06 KB - PDF)

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dansk (DA) (105.34 KB - PDF)

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Deutsch (DE) (108.16 KB - PDF)

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eesti keel (ET) (104.2 KB - PDF)

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ελληνικά (EL) (128.88 KB - PDF)

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français (FR) (110.09 KB - PDF)

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hrvatski (HR) (111.54 KB - PDF)

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íslenska (IS) (109.94 KB - PDF)

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italiano (IT) (103.52 KB - PDF)

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latviešu valoda (LV) (125.93 KB - PDF)

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lietuvių kalba (LT) (129.83 KB - PDF)

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magyar (HU) (115.09 KB - PDF)

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Malti (MT) (132.96 KB - PDF)

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Nederlands (NL) (102.01 KB - PDF)

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norsk (NO) (106.65 KB - PDF)

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polski (PL) (116.96 KB - PDF)

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português (PT) (103.33 KB - PDF)

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română (RO) (105.29 KB - PDF)

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slovenčina (SK) (125.95 KB - PDF)

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slovenščina (SL) (115.05 KB - PDF)

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Suomi (FI) (107.28 KB - PDF)

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svenska (SV) (104.7 KB - PDF)

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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 diseases

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.

Authorisation details

EMA product number
EMEA/H/C/005591
Marketing authorisation holder
Teva B.V.

Swensweg 5
2031GA Haarlem
The Netherlands

Opinion adopted
28/01/2021
Marketing authorisation issued
26/03/2021
Withdrawal of marketing authorisation
23/05/2025
Revision
4

Assessment history

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