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Vylaer Spiromax

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Status: Withdrawn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: Inhalation powder

Therapeutic Indication

Vylaer Spiromax is indicated in adults 18 years of age and older only.

Vylaer Spiromax 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The marketing authorisation for Vylaer Spiromax has been withdrawn at the request of the marketing authorisation holder.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.