COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Avalon» (18A04215)
Estratto provvedimento n. 382 del 23 maggio 2018 Medicinale veterinario AVALON Confezioni: AIC n. 104639 Titolare dell'A.I.C.: ACME s.r.l., Via Portella della Ginestra 9, Cavriago 42025, Reggio Emilia - RE Oggetto del provvedimento: raggruppamento di variazioni di tipo: IA - B.III.1.a.4 e IB unforeseen - C.II.z Si accettano le modifiche come di seguito descritte: soppressione del certificato di conformita' alla monografia di farmacopea europea del principio attivo Ivermectina del fornitore del fornitore Zhejiang Hisun Pharmaceutical Co. Ltd. sostituzione dell'imballaggio esterno per la sola confezione da 50 siringhe da scatola di cartone a secchiello in plastica. Per effetto delle suddette variazioni, si modificano i punti 6.5 e 8 dell'RCP, 11 e 15 del foglietto illustrativo e 4 dell'imballaggio esterno della confezione rappresentata dal secchiello in plastica, come di seguito indicato: RCP 6.5 Natura e composizione del condizionamento primario. Siringhe in polietilene ad alta densita' a dosaggio graduato per uso orale. Confezioni: scatola con una siringa di 7,49 g;
secchiello in plastica con 50 siringhe di 7,49 g. E' possibile che non tutte le confezioni siano commercializzate. 8. Numero(i)...
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