COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario ad azione immunologica «Duramune DAPPi + LC». (15A01947)
Estratto del provvedimento n. 66 del 2 febbraio 2015 Medicinale veterinario ad azione immunologica DURAMUNE DAPPi + LC (AIC n. 103664) per tutte le confezioni. Titolare A.I.C.: Zoetis Italia S.r.l, via Andrea Doria, 41 M 00192 - Roma. Oggetto del provvedimento: procedura di condivisione del lavoro: UK/V/xxxx/WS/022 Grouping di variazioni di tipo II. Si autorizza la modifica come di seguito descritta: tipo II. N. B.II.d.1 e). Modifica dei parametri di specifica e/o dei limiti del prodotto finito, modifica che non rientra nei limiti di specifica approvati. Si autorizza la modifica del titolo infettante per le valenze contenute nella frazione liofilizzata del vaccino. I nuovi limiti autorizzati...
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