På baggrund af sikkerhedsprofilen for Velcade, som kræver indsendelse af 6- måneders PSURer, har CHMP derfor besluttet, at indehaveren af markedsføringstilladelsen skal indsende yderligere en fornyelsesansøgning om 5 år.
Therefore, based upon the safety profile of Velcade, which requires the submission of 6-monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.