COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Strike» pasta orale. (15A00192)
Estratto del provvedimento n. 987 del 3 dicembre 2014 Medicinale veterinario STRIKE pasta orale Confezioni: - confezione da 1 siringa da 25 g - AIC n. 103942013 - confezione da 20 siringhe da 25 g - AIC n. 103942025 - confezione da 1 siringa da 50 g - AIC n. 103942037 - confezione da 1 tubo da 300 g - AIC n. 103942049 Titolare A.I.C.: ACME S.r.l VIA PORTELLA DELLA GINESTRA, 9 - 42025 CAVRIAGO REGGIO EMILIA Oggetto del provvedimento: Domanda di variazione IB, B.II.e.5.d : Modifica nella dimensione della confezione del prodotto finito. Modifica del peso/volume di riempimento di medicinali multi-dose (o a dose unica, utilizzo parziale) per uso non parenterale. Domanda di variazione IA, B.II.e.4.a : Modifica della forma o delle dimensioni del contenitore o della chiusura (confezionamento primario).Medicinali non sterili. Si autorizza, per il medicinale veterinario indicato in oggetto, la modifica concernente la sostituzione della siringa da 25 g con la siringa da 35 g nella confezione singola e nella confezione da 20 siringhe. Si autorizzano, pertanto, le seguenti nuove...
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