Vylaer Spiromax
budesonide / formoterol
Table of contents
Overview
The marketing authorisation for Vylaer Spiromax has been withdrawn at the request of the marketing authorisation holder.
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List item
Vylaer Spiromax : EPAR - Summary for the public (PDF/216.84 KB)
First published: 05/12/2014
Last updated: 05/12/2014
EMA/601032/2014 -
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List item
Vylaer Spiromax : EPAR - Risk-management-plan summary (PDF/237.74 KB)
First published: 05/12/2014
Last updated: 05/12/2014
EMA/675937/2014
Authorisation details
| Product details | |
|---|---|
| Name |
Vylaer Spiromax
|
| Agency product number |
EMEA/H/C/003952
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
R03AK07
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Teva Pharma B.V.
|
| Revision |
3
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/11/2014
|
| Contact address |
Computerweg 10
3542 DR Utrecht The Netherlands |
Product information
09/01/2017 Vylaer Spiromax - EMEA/H/C/003952 - A31/0003
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
Vylaer Spiromax is indicated in adults 18 years of age and older only.
Asthma
Vylaer Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
- in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
or - in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
COPD
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.