COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso veterinario «Drontal Plus Flavour 35 kg» per cani (19A00449)
Estratto del decreto n. 170 del 7 dicembre 2018 La societa' Farma 1000 S.r.L via Camperio Manfredo 9, 20123 Milano P.I. 12547530159, e' autorizzata all'importazione parallela dalla Polonia del medicinale DRONTAL PLUS FLAVOUR 35 kg scatola da due compresse per cani in blister, di cui autorizzazione 1398/03, 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. Importatore: societa' Farma 1000 S.r.l, via Camperio Manfredo, 9 - 20123 Milano - P.I. 12547530159;
Confezione da commercializzare: «Drontal plus flavour XL» per cani nella confezione da due compresse. Codice autorizzazione importazione parallela: 105333013. Forma farmaceutica: scatola da due compresse in blister. Medicinale autorizzato in Italia. Principi attivi: una compressa contiene: febantel 525,0 mg;
praziquantel 175,0 mg.;
pirantel embonato (pirantel pamoato) 504,0 mg. Eccipienti: amido di mais;
lattosio;
cellulosa microcristallina;
polividone;
magnesio stearato;
sodio laurilsolfato;
silice colloidale anidra;
aroma artificiale di carne irradiato. Medicinale importato, composizione quali-quantitativa acquisita dalla Polonia: 1.Qualitative and quantitative composition in terms of active ingredients and excipients: Name of active substance(s): febantel 525,0 mg;
praziquantel 175,0 mg.;
pirantel embonato 504,0 mg;
Name of excipient (s): corn starch;
lactose;
microcrystalline cellulose;
povidone;
mangnesium stearate;
sodium laurylsulphate;
colloidal anhydrous silica;
artificial beef flavor. Informazioni cliniche. Specie animali di destinazione: per cani del peso pari o superiore a 35 kg. Indicazioni per l'impiego, specificando le specie di destinazione. Per il controllo dei vermi tondi (ascaridi, ancilostomi, trichuridi) e tenie (compreso Echinococcus spp.), in particolare per le infestazioni da: 1. Ascaridi: toxocara canis;
toxascaris...
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