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Budesonide/Formoterol Teva

Active Substance: budesonide / formoterol fumarate dihydrate
Common Name: budesonide / formoterol
ATC Code: R03AK07
Marketing Authorisation Holder: Teva Pharma B.V.
Active Substance: budesonide / formoterol fumarate dihydrate
Status: Withdrawn
Authorisation Date: 2014-11-19
Therapeutic Area: Asthma Pulmonary Disease, Chronic Obstructive
Pharmacotherapeutic Group: Drugs for obstructive airway diseases

Therapeutic Indication

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

Asthma
Budesonide/Formoterol Teva 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.

The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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