OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SERETIDE EVOHALER
AND ASSOCIATED NAMES (SEE ANNEX I)
Seretide Evohaler and associated names (see Annex I of Opinion) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist (LABA) salmeterol and the inhaled corticosteroid (ICS) fluticasone propionate (FP) indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: -
patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and longacting
beta-2-agonist. In several EU Member States Seretide Evohaler and associated names (see Annex I) are approved through the Mutual Recognition Procedure (MRP). In the MRP the United Kingdom is the Reference Member State and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Iceland, Luxembourg, The Netherlands, Portugal, Spain and Sweden are Concerned Member States.