COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso veterinario «Synulox 50 mg» (18A06737)
Estratto decreto n. 121 del 24 settembre 2018 La Societa' GMM Farma s.r.l., con sede a Segrate (MI), in Via Lambretta 2, c.a.p. 20090, partita iva 07363361218, e' autorizzata all'importazione parallela dalla Polonia del medicinale veterinario SYNULOX 50 mg. 10 compresse appetibili, di cui all'autorizzazione n. 0615/98 citata nelle premesse, 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: Synulox 50 mg. 10 compresse appetibili;
Codice autorizzazione importazione parallela: 105292015;
Forma farmaceutica: 10 compresse;
Principi attivi: 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 dalla Polonia: 1. Qualitative and quantitative composition in terms of active ingredients and excipients: 1 tablet (175,00 mg) contains: - name of active substance (s): 1. amoxicillin - 40 mg (come amoxicillina triidrato) 2. clavulanic acid - 10 mg (come potassio clavulanato) - name of excipient (s): magnesium stearate;
colloidal anhydrous silica;
sodium carboxymethyl starch;
dried yeast;
erythrosine, wallflower (E 127);
microcrystalline cellulose. 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...
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