Budesonide/Formoterol Teva Pharma B.V.

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budesonide / formoterol fumarate dihydrate

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

Overview

Budesonide/Formoterol Teva Pharma B.V. is a medicine used for the treatment of asthma in adults 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;
  • whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ taken by inhalation.

Budesonide/Formoterol Teva Pharma B.V. 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.

Budesonide/Formoterol Teva Pharma B.V. is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler. The reference medicine for Budesonide/Formoterol Teva Pharma B.V. is Symbicort Turbohaler.

Budesonide/Formoterol Teva Pharma B.V. contains the active substances budesonide and formoterol.

This EPAR was last updated on 07/04/2020

Authorisation details

Product details
Name
Budesonide/Formoterol Teva Pharma B.V.
Agency product number
EMEA/H/C/004882
Active substance
budesonide / formoterol fumarate dihydrate
International non-proprietary name (INN) or common name
budesonide / formoterol fumarate dihydrate
Therapeutic area (MeSH)
  • Asthma
  • Pulmonary Disease, Chronic Obstructive
Anatomical therapeutic chemical (ATC) code
R03AK07
Publication details
Marketing-authorisation holder
Teva Pharma B.V. 
Date of issue of marketing authorisation valid throughout the European Union
03/04/2020
Contact address

Teva Pharma B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Budesonide/Formoterol Teva Pharma B.V. - EMEA/H/C/004882 -

Contents

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Pharmacotherapeutic group

Drugs for obstructive airway diseases

Therapeutic indication

Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.

Asthma

Budesonide/Formoterol Teva Pharma B.V. 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 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

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