BiResp Spiromax

RSS

budesonide / formoterol

Authorised
This medicine is authorised for use in the European Union.

Overview

BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used for the treatment ofto 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.

This EPAR was last updated on 09/06/2021

Authorisation details

Product details
Name
BiResp Spiromax
Agency product number
EMEA/H/C/003890
Active substance
  • budesonide
  • formoterol fumarate dihydrate
International non-proprietary name (INN) or common name
  • budesonide
  • formoterol
Therapeutic area (MeSH)
  • Pulmonary Disease, Chronic Obstructive
  • Asthma
Anatomical therapeutic chemical (ATC) code
R03AK07
Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
11
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

21/05/2021 BiResp Spiromax - EMEA/H/C/003890 - II/0033

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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