BiResp Spiromax
budesonide / formoterol
Table of contents
Overview
BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ (such as budesonide and formoterol) taken by inhalation.
BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
BiResp Spiromax is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but BiResp Spiromax is given using a different inhaler. The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
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List item
BiResp Spiromax : EPAR - Summary for the public (PDF/149.11 KB)
First published: 19/05/2014
Last updated: 09/06/2021
EMA/265709/2021 -
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List item
BiResp Spiromax : EPAR - Risk-management-plan summary (PDF/528.99 KB)
First published: 19/05/2014
Last updated: 09/06/2021
Authorisation details
| Product details | |
|---|---|
| Name |
BiResp Spiromax
|
| Agency product number |
EMEA/H/C/003890
|
| 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 |
12
|
| Date of issue of marketing authorisation valid throughout the European Union |
28/04/2014
|
| Contact address |
Computerweg 10
3542 DR Utrecht The Netherlands |
Product information
04/05/2023 BiResp Spiromax - EMEA/H/C/003890 - IA/0041
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
Asthma
BiResp Spiromax is indicated in adults and adolescents (12 years and older) for 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
BiResp Spiromax is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV₁) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.