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Budesonide/Formoterol Teva Pharma B.V.

Active Substance: budesonide / formoterol
Common Name: budesonide / formoterol fumarate dihydrate
ATC Code: R03AK07
Marketing Authorisation Holder: Teva Pharma B.V.
Active Substance: budesonide / formoterol
Status: Withdrawn
Authorisation Date: 2014-11-19
Therapeutic Area: Asthma
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.

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.

The marketing authorisation for Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at the request of the marketing-authorisation holder.

Source: European Medicines Agency

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