Seffalair Spiromax

RSS

salmeterol / fluticasone propionate

Authorised
This medicine is authorised for use in the European Union.

Overview

Seffalair 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.

This EPAR was last updated on 13/04/2021

Authorisation details

Product details
Name
Seffalair Spiromax
Agency product number
EMEA/H/C/004881
Active substance
  • fluticasone propionate
  • salmeterol xinafoate
International non-proprietary name (INN) or common name
  • salmeterol
  • fluticasone propionate
Therapeutic area (MeSH)
Asthma
Anatomical therapeutic chemical (ATC) code
R03AK06
Publication details
Marketing-authorisation holder
Teva B.V.
Date of issue of marketing authorisation valid throughout the European Union
26/03/2021
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

26/03/2021 Seffalair Spiromax - EMEA/H/C/004881 -

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Seffalair 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 β₂ agonists.

Assessment history

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