Vous avez cherché: psur (Maltais - Anglais)

psur
psurs

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:

(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).

psur’ s
psurs

l-ewwel psur
first psur

format ta’ psur simplifikat
format of the simplified psur

format tal-psur issimplifikat:
format of the simplified psur:

27 ta ’ diċembru 2008 psur 2:
27 december 2008 psur 2:

rapporti annwali se jiġu sottomessi mal-psur.
annual reports will be submitted with the psur.

(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).

rapporti ta’ studju interim – b’kull psur
interim study reports - with each psur

rapporti perjodiċi aġġornati dwar is-sigurtà (psur)
periodic safety update reports

għandha tkun inkluża dejta irrapurtata spontanjament biss fil-psur.
only spontaneously reported data should be included in the psur.

il-valutazzjoni dwar il-qsim tax-xogħol tal-psur
psur assessment worksharing

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.

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.

psur’ s għandhom jintbagħtu kull sena sat- tieni applikazzjoni ta ’ tiġdied.
psurs to be submitted annually until the second renewal application.

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.

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.

sottomissjoni ta’ s-psur lir-rapporteur u lis-chmp f’Ġurnata 45.
s-psur submission to the rapporteur and chmp members on day 45.