COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Hemo 15 soluzione iniettabile per cavalli bovini e suini». (18A06425)
Estratto provvedimento n. 632 del 10 settembre 2018 Medicinale veterinario: HEMO 15 soluzione iniettabile per cavalli bovini e suini - n. A.I.C. 100285016. Titolare A.I.C.: Equality S.r.l. Foro Buonaparte, 12 - 20121 Milano. Oggetto del provvedimento: raggruppamento di variazioni: variazione di tipo IA - B.II.b.5.b;
variazione di tipo IA - B.II.d.1.d;
variazione di tipo IB - B.II.d.1.g;
variazione di tipo II - B.II.e.1.a.3;
3 variazioni di tipo IA - B.II.e.7.b. Si autorizzano le seguenti modifiche: soppressione del parametro di specifica «Odore» per il prodotto finito;
sostituzione della specifica Pirogeni con la specifica «Endotossine batteriche», con il corrispondente metodo di prova, relativamente al prodotto finito. Il limite di specifica e': ≤
225 EU/ml;
sostituzione del flacone in vetro ambrato di tipo I con un flacone in vetro ambrato di tipo II, introduzione dei fornitori Aptar Stelmi (Francia) e Datwyler (Belgio) per il tappo in gomma;
introduzione del fornitore Pagani Capsule S.r.l. per le ghiere in alluminio a...
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