COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Sodio Cloruro 0,9%». (18A06428)
Estratto provvedimento n. 639 dell'11 settembre 2018 Medicinale veterinario: sodio cloruro 0,9% - A.I.C. n. 102321. Titolare A.I.C.: Industria Farmaceutica Galenica Senese S.r.l. - via Cassia Nord, 351 - Monteroni d'Arbia (Siena). Oggetto del provvedimento: variazione tipo IB, B.II.e.5.a.2: modifica nella dimensione della confezione del prodotto finito;
modifica del numero di unita' (compresse, fiale, ecc) in una confezione;
modifica al di fuori dei limiti delle dimensioni di confezione al momento approvate. Si autorizza, per il medicinale veterinario indicato in oggetto, la modifica di seguito descritta: aggiunta delle seguenti confezioni: scatola da 10 sacche in PVC da 1000 ml (A.I.C. n. 102321116);
scatola da 5 sacche in PVC da 2000 ml (A.I.C. n. 102321128);
scatola da 2 sacche in PVC da 5000 ml (A.I.C. n. 102321130). Per effetto della suddetta variazione gli stampati devono essere modificati come segue: RCP - 8 numeri dell'autorizzazione all'immissione in commercio: flacone da 100 ml - A.I.C. n. 102321015;
flacone da 250 ml - A.I.C. n. 102321027;
flacone da 500 ml - A.I.C. n. 102321039;
sacca da 500 ml - A.I.C. n. 102321080;
sacca da 1000 ml - A.I.C. n. 102321041;
...
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