COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Flordofen 300 mg/ml» soluzione iniettabile per bovini e suini. (16A05870)
Estratto del provvedimento n. 445 dell'8 luglio 2016 Medicinale veterinario: FLORDOFEN 300 mg/ml - soluzione iniettabile per bovini e suini. Confezioni: A.I.C. n. 104588. Titolare A.I.C.: Dopharma Research B.V. Zalmweg 24 - 4941 VX, Raamsdonksveer - The Netherlands. Oggetto del provvedimento: Procedura Europea n. PT/V/0112/001/II/002/G. Si autorizzano, per il medicinale veterinario indicato in oggetto, le seguenti modifiche: La societa' Dopharma B.V., Zalmweg, 24 - 4941 VX Raamsdonksveer - The Netherlands, come sito responsabile del rilascio dei lotti del prodotto finito, in sostituzione del sito Laboratorios Calier S.A. - Spagna. Aggiunta di tre nuove confezioni del prodotto finito e precisamente: flacone in vetro da 50 ml - A.I.C. n. 104588025;
flacone in vetro da 100 ml - A.I.C. n. 104588037;
flacone in vetro da 250 ml - A.I.C. n. 104588049. Le variazioni sopra indicate comportano la modifica delle seguenti sezioni del RCP e relative sezioni delle etichette e del foglietto illustrativo: 6.3 Periodo di validita'. Periodo di validita' del medicinale veterinario confezionato per la vendita: flacone in polipropilene: 2 anni;
flacone in vetro: 12 mesi. Periodo di validita' dopo prima apertura del confezionamento primario: 28 giorni. 6.4 Speciale precauzioni per la conservazione: conservare a una temperatura inferiore ai 25°C;
tenere il flacone nell'imballaggio esterno per proteggerlo dalla luce. 6.5 Natura e composizione del confezionamento primario: flacone in polipropilene da 250 ml, chiuso con un tappo di gomma bromobutilica e sigillato con una capsula di chiusura in alluminio dotata di dischetto flip off rimovibile;
flacone incolore di vetro di tipo II da 50 ml o da 100 ml chiuso con un tappo di gomma bromobutilica e sigillato con ghiera di alluminio;
flacone di vetro ambrato di tipo II da 250 ml chiuso con un tappo di gomma bromobutilica e sigillato con una ghiera di...
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