Udvalget tog desuden i betragtning, at de foreslåede tiltag til risikominimering ikke gør det muligt at mindske risiciene til et acceptabelt niveau eller forudsige, hvilke kvinder, der kan være udsat for risiko • CHMP konkluderede derfor, at benefit/ risk- forholdet for lægemidler indeholdende veraliprid ikke er gunstigt under normale anvendelsesbetingelser
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk; • The Committee, as a consequence, concluded that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.