Salmeterol/Fluticasone STADA 25 μg/50 μg/dose, 25 μg/125 μg/dose and 25 μg/250 μg/dose, aerosol, suspension - public assessment report refusal of application

This was an application procedure for an aerosol-suspension containing two known active ingredients: salmeterol and fluticasone. The applicant claimed therapeutic equivalence to the innovator product Seretide Evohaler. Based on the study results that were submitted, the MEB deemed that the efficacy and safety were not equivalent to those of the Seretide Evohaler. The decentralised procedure was completed with a negative outcome. The marketing authorisation was not granted.