Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Efexor Depot i EU- medlemsstaterne, med hensyn til behandling af svære depressive episoder, til forebyggelse af recidiverende svære depressive episoder, behandling af social angst, panikangst med eller uden agorafobi og generaliseret angst.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Efexor depot approved across EU Member States, with respect to the treatment of major depressive episodes, the prevention of recurrence of major depressive episodes, the treatment of social anxiety disorder, panic disorders with or without agoraphobia, and generalized anxiety disorder.