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the frequencies are based on the most recent clinical trial and non interventional safety survey.
il-frekwenzi huma bbażati fuq l-aktar prova klinika riċenti u stħarriġ fuq is-sigurtà mhux intervenzjonali.
6.4 information on non-interventional scientific studies should not be disseminated to the public.
6.4 fil-fehma tal-kumitat, l-informazzjoni dwar studji xjentifiċi mingħajr intervent m’għandhiex tinxtered fost il-pubbliku inġenerali.
medicinal product-related information on non-interventional scientific studies is also to be allowed.
skont il-proposta għal direttiva għandha tiġi permessa wkoll l-informazzjoni mediċinali marbuta mal-prodott dwar studji xjentifiċi mingħajr intervent.
rivaroxaban has not been studied in interventional clinical trials in patients undergoing hip fracture surgery to evaluate efficacy and safety.
rivaroxaban ma kienx studjat fi provi kliniċi ta’ intervent f’pazjenti li għamlu kirurġija tal-ksur tal- ġenbejn biex jiġu stmati l-effikaċja u s-sigurtà.
adverse drug reactions derived from post-marketing reports other than interventional clinical trials are printed in italics.
reazzjonijiet avversi tal-mediċina miksuba minn rapporti ta’ wara t-tqegħid fis-suq, ħlief provi kliniċi intervenzjonali, huma stampati b’tipa korsiva.
(c) involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy.
(c) li jinvolvi dożi għoljin għall-pazjent, bħar-radjoloġija ta' intervent, it-tomografija komputata jew ir-radjoterapija.
(jjjjjj) involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy.
(c) li jinvolvi dożi għoljin għall-pazjent, bħar-radjoloġija ta' intervent, it-tomografija komputata jew ir-radjoterapija.
(4) ‘non-interventional study’: a clinical study other than a clinical trial;
(4) "studju mingħajr intervent": studju kliniku għajr prova klinika;
a non-interventional post-authorisation safety study was conducted which involved 300 patients undergoing vascular surgery during which evicel was used.
twettaq studju dwar is-sigurtà, mingħajr interventi, wara l-awtorizzazzjoni, li kien jinvolvi 300 pazjent li kienu għaddejjin minn kirurġija vaskulari, li matulha intuża evicel.
the clinical trials directive applies only to ‘interventional trials’, but not to ‘non-interventional’ trials.
id-direttiva dwar il-provi kliniċi tapplika biss għal "provi b'intervent", iżda mhux għal provi "mingħajr intervent".