Ud - valget vedtog derfor den 24. maj 2007 en udtalelse, der anbefaler opretholdelse eller, i givet fald, udste - delse af markedsføringstilladelse, med ændringer i de relevante punkter af produktresumeet, for produkter indeholdende bicalutamid, 150 mg.
Based on evaluation of the available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of bicalutamide 150 mg-containing medicinal products remains favourable, and therefore adopted an opinion on 24 May 2007 recommending the maintenance or the granting, as appropriate, of the Marketing Authorisations with amendments to the relevant sections of the Summary of Product Characteristics, for bicalutamide 150 mg-containing medicinal products.