Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Zyrtec og tilknyttede navne i EU- medlemsstaterne, især med hensyn til indikationer, dosering, kontraindikationer og særlige advarsler.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.