Vous avez cherché: bibljografika (Maltais - Anglais)

applikazzjoni bbażata fuq dejta bibljografika
application based on bibliographic data

fil-parti ta' wara tal-pubblikazzjoni ssib skeda bibljografika.
c a ta l o g u in g d a ta can be found a t the end o f th is p u b l i c a t i o n

għandhom jiġu inklużi deskrizzjoni dettaljata u sħiħa dwar l-istudji mwettqa u l-metodi użati jew referenza bibljografika għal dawk il-metodi.
a detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods shall be included.

globalment, it- tweġibiet ipprovduti inkludew dejta bibljografika u proposta għall- aġġornament tas- sezzjoni 5. 1 tal - spc.
overall, the responses provided included bibliographical data and a proposal to update the section 5.1 of the spc.

barra minn hekk, l - applikant issottometta diversi studji kliniċi mwettqa f' popolazzjonijiet li huma rappreżentattivi tal - popolazzjonijiet indikati fl- spc bħala referenza bibljografika, li jikkonfermaw l- effikaċja ta ’ uman big fl- indikazzjonijiet iddikjarati.
in addition, the applicant submitted several clinical studies conducted in populations that are representative of the populations indicated in the spc as bibliographic reference, which confirm the efficacy of uman big in the claimed indications.