COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso veterinario «Drontal Plus Flavour 35Kg». (17A03275)
Estratto decreto n. 52 del 14 aprile 2017 E' autorizzata l'importazione parallela del medicinale veterinario, DRONTAL PLUS FLAVOUR 35 kg, che deve essere messo in commercio con la denominazione e con le specificazioni di seguito indicate, e a condizione che siano valide ed efficaci alla data di entrata in vigore del presente decreto. Importatore: Societa' Four Pharma Cro srl via Monti, 12 - 00034 Colleferro (Roma). Confezione da commercializzare: : Drontal Plus Flavour 35 kg. Codice autorizzazione importazione parallela: 105115012. Principi attivi: 1 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: 1 tablet (175,00 mg) contains: 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. Specie di destinazione: cani. Indicazioni terapeutiche: per cani del peso pari o superiore a 35 kg. 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 leonina | +-----------------------+---------------------------+ |2. Ancilostomi |Ancylostoma caninum | +-----------------------+---------------------------+ | |Uncinaria stenocephala | +-----------------------+---------------------------+ |3. Trichuridi |Trichuris vulpis |...
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