Airexar Spiromax


salmeterol xinafoate / fluticasone propionate

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Airexar Spiromax has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 02/07/2019

Authorisation details

Product details
Airexar Spiromax
Agency product number
Active substance
  • salmeterol
  • fluticasone propionate
International non-proprietary name (INN) or common name
  • salmeterol xinafoate
  • fluticasone propionate
Therapeutic area (MeSH)
  • Pulmonary Disease, Chronic Obstructive
  • Asthma
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Teva B.V.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

19/02/2018 Airexar Spiromax - EMEA/H/C/004267 - IAIN/0003

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Product information documents contain:

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

Airexar Spiromax is indicated for use in adults aged 18 years and older only.

Airexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:

- patients not adequately controlled on a lower strength corticosteroid combination product


- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.

Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Assessment history

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