COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso veterinario «Synulox». (19A05621)
Estratto decreto n. 108 del 15 luglio 2019 La Societa' BBFarma S.r.l., viale Europa 160 - 21017 Samarate (VA) Italia, P.I. 02180370021, e' autorizzata all'importazione parallela dal Belgio del medicinale veterinario SYNULOX 50 mg, 100 comprimes appetents, di cui all'autorizzazione di autorizzazione, BE-V131092, con le specificazioni di seguito indicate, a condizione che siano valide ed efficaci al momento dell'entrata in vigore del presente decreto: confezione da commercializzare: medicinale veterinario SYNULOX 50 mg, 10 compresse appetibili;
codice autorizzazione importazione parallela: 105423014. Medicinale autorizzato in Italia: principi attivi: una compressa da 50 mg contiene: Amoxicillina mg 40, come Amoxicillina Triidrato 45 mg;
Acido Clavulanico mg 10, come Potassio Clavulanato 11,9 mg;
eccipienti: magnesio stearato, sodio amido glicolato (tipo A), silice colloidale anidra, cellulosa microcristallina, eritrosina (E127), lievito essiccato. Medicinale importato, composizione quali-quantitativa acquisita dal Belgio: ogni compressa da mg 50 contiene rispettivamente: principi attivi: amoxicillina mg 40 equivalente a amoxicillina triidrato mg 45,0;
acido clavulanico mg 10 equivalente a potassio clavulanato mg 11,9;
eccipienti: eritrosina (E127). Specie di destinazione: cani e gatti. Indicazioni terapeutiche: in vitro, SYNULOX e' efficace contro un'ampia gamma di batteri clinicamente importanti, fra cui: Gram positivi: Stafilococchi (compresi i ceppi produttori di beta-lattamasi), Streptococchi, Peptostreptococcus spp., Corinebatteri e Clostridi;
Gram negativi: Escherichia coli (compresi i ceppi produttori di beta-lattamasi)...
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