Risk/ benefit- hensyn På grundlag af den af ansøgeren indleverede dokumentation, herunder forslaget om indførelse af et svangerskabsforebyggende program, og udvalgets faglige drøftelser fandt CPMP, at benefit/ risk - forholdet for Isotretinoin / Lurantal / Rexidal / Scheritonin / Trivane er gunstigt til de godkendte indikationer.
Benefit/ Risk considerations Based on the documentation submitted by the applicant including the proposal for implementation of a pregnancy prevention programme and the scientific discussion within the Committee, the CPMP considered that the benefit/ risk ratio of Isotretinoin / Lurantal / Rexidal / Scheritonin / Trivane is positive for the agreed indications.