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grajja ta' qawmien:
wake event:
Last Update: 2014-11-14
Usage Frequency: 2
Quality:
iktar minn hekk, l- rmp aġġornat irid jkun mogħti • meta hemm informazzjoni ġdida li jista jkollha effett fuq l- ispeċifikazzjoni tas- sigurtà, pjan ta ’ farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju • fi żmien 60- il ġurnata ta xi grajja importanti (farmacoviġilanza jew tnaqqis tar- riskju) li tkun intlaħqet • fuq talba tal- emea
19 in addition, an updated rmp should be submitted • when new information is received that may impact on the current safety specification, pharmacovigilance plan or risk minimisation activities • within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • at the request of the emea
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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