COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Vibragest 4mg/ml» soluzione orale per suini. (17A00639)
Estratto provvedimento n. 847 del 22 dicembre 2016 Medicinale veterinario VIBRAGEST 4 mg/ml soluzione orale per suini. Confezioni: flacone da 450 ml - AIC n. 104166018;
flacone da 900 ml - AIC n. 104166020. Titolare dell'A.I.C.: Virbac, 1ere Avenue - 2065m - LID, 06516 Carros Cedex, France. Oggetto del provvedimento: procedura di mutuo riconoscimento: UK/V/0237/001/IA/005. Si conferma l'accettazione della modifica come di seguito descritta: «Modifica degli stampati illustrativi del medicinale in oggetto a seguito alla decisione della Commissione europea C(2016) 5073 final del 29 luglio 2016». Per effetto della suddetta variazione gli stampati devono essere modificati come segue: Riassunto delle caratteristiche del prodotto (RCP). Punto 4.5 - Precauzioni speciali per l'impiego. Aggiungere il seguente paragrafo: «Altre precauzioni che riguardano l'impatto sull'ambiente. Quando si sparge il letame degli animali trattati, deve essere rigorosamente rispettata la distanza minima della superfice dell'acqua, come definito dalla normativa nazionale o locale, poiche' il letame puo' contenere altrenogest che potrebbe causare effetti negativi per l'ambiente acquatico». Punto 6.6 - Precauzioni particolari da prendere per lo smaltimento del medicinale veterinario non utilizzato e dei rifiuti derivanti dal suo utilizzo. Sostituire la frase presente con le seguenti: «Vibragest non deve essere disperso nei corsi d'acqua poiche' potrebbe essere pericoloso per i pesci o per altri organismi acquatici. Il medicinale veterinario non utilizzato o i rifiuti derivati da tale medicinale veterinario devono essere smaltiti in...
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