På baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget var CHMP på sit møde i september 2007 af den opfattelse, at benefit/ risk- forholdet er gunstigt for Bicaluplex og tilknyttede navne, at de indsigelser, der er rejst af Tyskland, ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
During their September 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.