COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Prontobario HD» (17A08720)
Estratto determina AAM/PPA n. 1174 dell'11 dicembre 2017 Autorizzazione della variazione: B.I.d.1.e). Relativamente al medicinale: «PRONTOBARIO HD». Titolare A.I.C.: Bracco Imaging Italia S.r.l. (codice fiscale 05501420961) con sede legale e domicilio fiscale in via Folli Egidio, 50, 20134 - Milano (MI) Italia. Codice pratica: VN2/2016/289. E' autorizzata la seguente variazione: modifica dei limiti di specifica relativi al Bario Sulphate Assay come sotto riportati: da Barium sulphate assay - Compreso fra 97,5% e 102,5 % w/w a Barium sulphate assay - 95.0 - 105.0% Label Claim (Label Claim 98% w/w) relativamente al medicinale «PRONTOBARIO HD», nelle...
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