− Yderligere data om muligheden, for at behandling med bortezomib, foruden proteasomhæmning, kan forårsage øget risiko for amyloidose og/ eller have utilsigtet effekt på sygdommens udvikling og organpåvirkninger, skal vurderes som en del af en specifik forpligtelse.
− Further data on the possibility that secondary to proteasome inhibition, bortezomib treatment may increase the risk of amyloidosis and/ or may have an adverse impact on its progression and organ manifestations is to be assessed as part of a specific obligation.