budesonide-formoterol (Symbicort)

in the absence of a submission from the holder of the marketing authorisation:

budesonide/formoterol inhalation powder (Symbicort Turbohaler®) and pressurised inhalation, suspension (Symbicort®) are not recommended for use within NHS Scotland.

Indication under review: Treatment of patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 50% to 70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this patient group.  As a result we cannot recommend its use within NHSScotland.
 
SMC has previously issued accepted advice (97/04) for budesonide/formoterol inhaler (Symbicort Turbohaler) for the 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.  This advice may be extended to (Symbicort®) pressurised inhalation, suspension.