COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso veterinario «Paramore e Paromomicina Huvepharma». (18A04521)
Estratto provvedimento n. 434 del 14 giugno 2018 Medicinali veterinari Paramore, 200 mg/ml soluzione per uso orale per vitelli da latte, suini, broiler, tacchini e conigli - A.I.C. n. 104735. Paromomicina Huvepharma 200 g/kg premiscela per alimenti medicamentosi per suini, polli da carne (broiler), conigli e tacchini - A.I.C. n. 104526. Titolare A.I.C.: Huvepharma N. V. Uitbreidingstraat 80 2600 Anversa Belgio. Oggetto del provvedimento: variazione tipo IB, n. C.I.2. Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo di un medicinale generico/ibrido/biosimilare in seguito a una valutazione della stessa modifica apportata al prodotto di riferimento. Si autorizzano le modifiche dei paragrafi 4.9 «Posologia» e 4.11 «Tempo (i) di attesa» del riassunto delle caratteristiche del prodotto e dei corrispondenti paragrafi delle etichette/foglietto illustrativo (par. 9 e 10) come segue: PARAMORE - A.I.C. n. 104735. Eliminare le seguenti posologie e tempi di attesa dai paragrafi citati: 4.9 Posologia e via di somministrazione «Suini (fino a 50 kg): 8,5 mg di principio attivo/kg p.v. (pari a 4,25 ml di prodotto/100 kg di peso vivo) per 21 giorni»;
Conigli: «10 mg di principio attivo/kg p.v. (pari a 5 ml di prodotto/100 kg di peso vivo) per 21 giorni». 4.11 Tempo(i) di attesa «Suini (fino a 50 kg): carni e visceri 44 giorni»;
Conigli (per trattamento 21 giorni): carni...
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