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ippre para s-sit għall-inje zzjoni skont kif qalle k it-tabib lew l-ispiżjar tiegħek.
prepare the injection site as directed by your doctor or pharmacist.
Last Update: 2017-04-26
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sistema ta ’ farmakovi ilanza id- detentur ta ’ l- awtorizzazzjoni g at- tqeg id fis- suq g andu ji gura li s- sistema ta ’ farmakovi ilanza, kif deskritta fil- ver joni 2 ippre entata fil- modulu 1. 8. 1. ta ’ l- applikazzjoni ta ’ l - awtorizzazzjoni g at- tqeg id fis- suq u kwalunkwe a ustament sussegwenti, ikun fis- se u li din tkun qed ta dem qabel u waqt li l- prodott ikun fis- suq pjan ta ’ l- immani ar tar- riskji id- detentur ta ’ l- awtorizzazzjoni g at- tqeg id fis- suq jikkommetti ru u li jwettaq l- istudji u l - attivitajiet ta ’ farmakovi ilanza addizzjonali mog tija fid- dettall fil- pjan ta ’ farmakovi ilanza, kif sar qbil fuqhom fil- ver joni 1. 1 tal- pjan ta ’ l- immani ar tar- riskji (rmp) ippre entat fil- modulu 1. 8. 2. ta ’ l- applikazzjoni g all- awtorizzazzjoni g at- tqeg id fis- suq u kull a ornament sussegwenti tal - rmp li jkun sar qbil fuqu mill- chmp.
risk management plan the mah commits to performing the studies and additional pharmacovigilance activities detailed in the pharmacovigilance plan, as agreed in version 1.1 of the risk management plan (rmp) presented in module 1.8.2. of the marketing authorisation application and any subsequent updates of the rmp agreed by the chmp.
Last Update: 2011-10-23
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