Seffalair Spiromax
salmeterol / fluticasone propionate
Table of contents
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.
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Seffalair Spiromax : EPAR - Medicine overview (PDF/133.38 KB)
First published: 13/04/2021
EMA/67034/2021 -
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Seffalair Spiromax : EPAR - Risk-management-plan summary (PDF/103.76 KB)
First published: 13/04/2021
Authorisation details
Product details | |
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Name |
Seffalair Spiromax
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Agency product number |
EMEA/H/C/004881
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Asthma
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Anatomical therapeutic chemical (ATC) code |
R03AK06
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Publication details | |
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Marketing-authorisation holder |
Teva B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
26/03/2021
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Contact address |
Swensweg 5 |
Product information
15/07/2021 Seffalair Spiromax - EMEA/H/C/004881 - IB/0001
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.