COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Zirtec» (15A02707)
Estratto determina V&A IP n. 569 del 20 marzo 2015 E' autorizzata l'importazione parallela del medicinale ZYRTEC 10 mg tabletki powlekane (film coated tablet) 20 tabl. dalla Polonia con numero di autorizzazione R/1846, con le specificazioni di seguito indicate e a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione. Importatore: New Pharmashop S.r.l. CIS di Nola Isola 1 - Torre 1 - Int. 120 - 80035 Nola. Confezione: Zirtec "10 mg compresse rivestite con film" 20 compresse. Codice AIC: 043824010 (in base 10) 19TDWB (in base 32). Forma Farmaceutica: compresse rivestite con film. Ogni compressa rivestita contiene: Principio attivo: Cetirizina dicloridrato 10 mg. Eccipienti: nucleo della compressa: lattosio monoidrato, cellulosa microcristallina, silice colloidale anidra, magnesio stearato. Film di rivestimento: Opadry Y-1-7000 (ipromellosa, titanio diossido (E 171), macrogol 400). Indicazioni terapeutiche: Adulti e pazienti pediatrici a partire da 6 anni di eta': Cetirizina e' indicata per il trattamento dei sintomi nasali e oculari della rinite allergica stagionale e perenne. Cetirizina e' indicata per il trattamento sintomatico dell'orticaria cronica idiopatica. Confezionamento secondario. E' autorizzato il confezionamento secondario presso le officine Pharm@Idea S.r.l. via del Commercio, 5 - 25039 Travagliato (BS);
S.C.F. S.n.c. Di Giovenzana...
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