Risk/ benefit- hensyn På grundlag af den af indehaveren af markedsføringstilladelsen indleverede dokumentation, herunder forslaget om indførelse af et svangerskabsforebyggende program, og udvalgets faglige drøftelser fandt CPMP, at benefit/ risk- forholdet for Roaccutan (og tilknyttede navne) er gunstigt for de godkendte indikationer.
Benefit/ Risk considerations Based on the documentation submitted by the Marketing Authorisation Holders 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 Roaccutane (and associated names) is positive for the agreed indications.