COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio dei medicinali per uso umano «Influvac S - Batrevac». (13A07203)
Estratto determinazione V &
A/1311 del 23 luglio 2013 Specialita' medicinali: INFLUVAC S - BATREVAC Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento per le specialita' sopra indicate Titolare AIC: Abbott S.R.L. N° Procedura mutuo riconoscimento: NL/H/XXXX/WS/045 Tipo di modifica: B.I.b.2 Modifica nella procedura di prova del principio attivo o delle materie prime, reattivi o sostanze intermedie utilizzati nel procedimento di fabbricazione del principio attivo d) Modifica (sostituzione) in un metodo di prova biologico, immunologico o immunochimico o in un metodo che utilizza un reattivo biologico per un principio attivo biologico, ad esempio impronta proteica, impronta glucidica, ecc. Modifica apportata: modifiche minori della procedura analitica: "Single Radial Diffusion (SRD) assay per la determinazione del contenuto dell'antigene emoagglutinina" da: "Determinazione del contenuto di emoagglutinina tramite Single Radial Diffusion " a: "Determinazione del contenuto di...
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