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psur
psurs
Last Update: 2017-04-26
Usage Frequency: 3
Quality:
psur:
official batch release: in accordance with article 114 of directive 2001/ 83/ ec as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose psur:
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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(psur)
as per the chmp guideline on risk management systems for medicinal products for human use, the updated rmp should be submitted at the same time as the next periodic safety update report (psur).
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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psur’ s
psurs
Last Update: 2012-04-10
Usage Frequency: 2
Quality:
l-ewwel psur
first psur
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
format ta’ psur simplifikat
format of the simplified psur
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
format tal-psur issimplifikat:
format of the simplified psur:
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
27 ta ’ diċembru 2008 psur 2:
27 december 2008 psur 2:
Last Update: 2011-10-23
Usage Frequency: 4
Quality:
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rapporti annwali se jiġu sottomessi mal-psur.
annual reports will be submitted with the psur.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
(psur - periodic safety update report)
as per the chmp guideline on risk management systems for medicinal products for human use, the updated rmp should be submitted at the same time as the next periodic safety update report (psur).
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.
rapporti ta’ studju interim – b’kull psur
interim study reports - with each psur
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
rapporti perjodiċi aġġornati dwar is-sigurtà (psur)
periodic safety update reports
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
għandha tkun inkluża dejta irrapurtata spontanjament biss fil-psur.
only spontaneously reported data should be included in the psur.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
il-valutazzjoni dwar il-qsim tax-xogħol tal-psur
psur assessment worksharing
Last Update: 2017-04-06
Usage Frequency: 1
Quality:
is-chmp iddeċieda li l-mah għandu jkompli jissottometti psur kull sena.
the chmp decided that the mah should continue to submit 1-yearly psurs.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
psur speċifiku għat- tfal li jirrapporta sottomissjonijiet lill- awtoritajiet regolatorja ser isir kull 6 xhur
paediatric specific psur reporting submissions to regulatory authorities will be made every 6 months for the first 2 years following approval of the expanded paediatric indicationfor nespo in the ckd setting.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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psur’ s għandhom jintbagħtu kull sena sat- tieni applikazzjoni ta ’ tiġdied.
psurs to be submitted annually until the second renewal application.
Last Update: 2011-10-23
Usage Frequency: 1
Quality:
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dawk li jkunu għadhom mhux imdaħħla għandhom ikunu irrapurtati fl-s-psur li jmiss.
those which have not yet been entered should be reported in the following s- psur.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
ażżma u każijiet ta’ sintomi relatati mal-ażżma ġew evalwati fil-psur preżenti.
asthma and asthma- related symptoms cases were evaluated in the present psur.
Last Update: 2017-04-26
Usage Frequency: 1
Quality:
sottomissjoni ta’ s-psur lir-rapporteur u lis-chmp f’Ġurnata 45.
s-psur submission to the rapporteur and chmp members on day 45.
Last Update: 2017-04-26
Usage Frequency: 1
Quality: