Yderligere skal en opdateret risikostyringsplan udleveres • Når der modtages ny information, som kan have indvirkning på den aktuelle sikkerhedsspecifikation, på den aktuelle farmakovigilanceplan eller på risikoreducerende aktiviteter • Inden for 60 dage efter at en vigtig (farmakovigilance - eller risikoreducerende) milepæl nås • På anmodning fra EMEA
Male patients • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate semen during therapy and for one week following discontinuation of thalidomide