Baseret på data modtaget efter godkendelse af den første markedsføringstilladelse, anser CHMP, at risk/ benefit- forholdet for Advate stadig er positivt, men mener, at sikkerhedsprofilen skal overvåges nøje af følgende grunde:
Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit/risk balance of Advate remains positive, but considers that its safety profile is to be closely monitored for the following reasons: