COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Speciorlac». (14A06504)
Estratto provvedimento n. 607 del 22 luglio 2014 Medicinale veterinario SPECIORLAC (A.I.C. n. 101331). Confezioni: 015 - 4 tubi siringa;
027 - 100 tubi siringa. Titolare A.I.C.: Merial Italia SpA, con sede legale in Milano, via Vittor Pisani n. 16 - codice fiscale 00221300288. Modifica: variazione di tipo IB: B.II.f.1 a) 1. Modifica della durata di conservazione o delle condizioni di stoccaggio del prodotto finito. Riduzione della durata di conservazione del prodotto finito cosi' come confezionato per la vendita;
variazione di tipo IB: B.II.f.1 d) 1. Modifica della durata di conservazione o delle condizioni di stoccaggio del prodotto finito. Modifica delle condizioni di stoccaggio del prodotto finito o del prodotto diluito/ricostituito. Si autorizzano le modifiche indicate in oggetto, come di seguito descritte: la riduzione del periodo di validita' del medicinale confezionato per la vendita da 24 mesi a 18 mesi;
la modifica delle condizioni di conservazione del prodotto finito da «Conservare in luogo fresco» a «Conservare a temperatura inferiore a 25° C». Per effetto delle suddette variazioni il «Riassunto delle...
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