Grundlaget for indbringelsen var, at der var afvigelser i produktresumeerne (SPC) for Cozaar Comp. og tilknyttede navne, som er godkendt i alle EU- medlemsstaterne, med henblik på følgende indikationer:
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Cozaar Comp. and associated names approved across EU Member States, with respect to the following indications: