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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Status: Withdrawn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.

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.
  • in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.

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The marketing authorisation for Budesonide/Formoterol Teva has been withdrawn at the request of the marketing-authorisation holder.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.