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in order to comply with the nfg on evaluation of medicinal products indicated for treatment of bacterial infections (cpmp/ ewp/ 558/ 95 rev.1), the applicant accepted that proposed spc should be updated in due time to include eucast breakpoints.
4 biex ikun konformi ma ’ nfg dwar il- valutazzjoni tal- prodotti mediċinali indikati għat - trattament ta ’ l- infezzjonijiet batterjali (cpmp/ ewp/ 558/ 95 rev. 1), l- applikant aċċetta li l - spc propost jiġi aġġornat fi żmien xieraq biex jinkludi il- valuri kritiċi ta ’ l- eucast.
Last Update: 2012-04-10
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