Airexar Spiromax
salmeterol xinafoate / fluticasone propionate
Table of contents
Overview
The marketing authorisation for Airexar Spiromax has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Airexar Spiromax
|
| Agency product number |
EMEA/H/C/004267
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
R03AK06
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva B.V.
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
18/08/2016
|
| Contact address |
Swensweg 5 |
Product information
19/02/2018 Airexar Spiromax - EMEA/H/C/004267 - IAIN/0003
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).
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.
Asthma
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
or
- 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.