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psur
vakim
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
psur.
psur-om.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
first psur
prvi psur
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
psur/ annual reassessment
psur/godišnja procjena
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
format of the simplified psur
format pojednostavljenog psur-a
Last Update: 2017-04-26
Usage Frequency: 2
Quality:
interim study reports - with each psur
privremena izvješća ispitivanja – sa svakim psur-om
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
submission of study protocol with first psur
predavanje protokola ispitivanja s prvim psur- om
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
annual reports will be submitted with the psur.
godišnja izvješća će se podnositi uz periodičko izvješće o neškodljivosti lijeka (psur).
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
only spontaneously reported data should be included in the psur.
u psur bi trebalo uključiti samo spontane prijave.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
psur submission when aflunov is used during an influenza pandemic:
podnošenje psura kad se aflunov koristi tijekom pandemije influence:
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
interim data submitted in each psur final study report by 30 september 2016
privremeni podaci predaju se uz svaki psur završno izvješće o ispitivanju do 30. rujna 2016.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the additional four cases were reported after this psur was submitted for assessment.
preostala četiri slučaja bila su prijavljena nakon podnošenja ovog psur-a na procjenu.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
data collected in this registry should be reported to the chmp at the time of psur submissions.
podatke prikupljene u ovom registru treba prijaviti chmp-u istovremeno s podnošenjem psur-a.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
6 months in line with the periodic safety update report (psur) cycle
podatke chmp-u svakih 6 mjeseci u skladu s ciklusom perdiodičkih
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
if the submission of a psur and the update of a rmp coincide, they can be submitted at the same time.
ako se podnošenje periodičkog izvješća o neškodljivosti (psur) podudara s nadopunama plana (rmp), dokumenti mogu biti podneseni istodobno.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
14 cases of nightmare were reviewed in the current psur, which included cases of both positive dechallenge and rechallenge.
u ovom psur-u pregledano je 14 slučajeva noćnih mora, koji su uključivali slučajeve s pozitivnim dechallenge-om i rechallenge-om.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
outside of the pandemic period, the normal psur periodicity and format will be maintained, with a specific review of aesi.
izvan razdoblja pandemije bit će zadržana uobičajena periodičnost i format psur-a, uz specifičan pregled aesi-a.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the psur cycle for the medicinal product should follow a twice-yearly cycle until otherwise agreed by the chmp.
podnošenje psur-a za lijek treba pratiti ciklus od dva puta godišnje do drugačije dogovorenog od strane chmp-a.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the psur cycle of extavia is aligned with the cross-referred product, betaferon, until otherwise specified.
periodičnost psur-eva extavije usklađena je s referentnim lijekom betaferon, dok ne bude drugačije naznačeno.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
the psur cycle of icandra will correspond to the one attributed to the cross-referred product, eucreas, until otherwise specified.
ciklus psur-ova za icandru odgovarat će onome određenom za referentni lijek eucreas, osim ako je drugačije navedeno.
Last Update: 2017-04-26
Usage Frequency: 1
Quality: