Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Risperdal og tilknyttede navne i EU- medlemsstaterne, med hensyn til indikationer, dosering og indgivelsesmåde, kontraindikationer, særlige advarsler og forsigtighedsregler vedrørende brugen og interaktionen med andre lægemidler og andre former for interaktion.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal and associated names approved across EU Member States, with respect to the indications, the posology and method of administration, the contra-indications, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.