COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Reactine» (18A00285)
Estratto determina IP n. 669 del 4 dicembre 2017 E' autorizzata l'importazione parallela del medicinale REACTINE Pseudoephedrine 5 mg/ 120 mg Prolonged-release tablets 14 tablets dal Belgio con numero di autorizzazione BE257257, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: Importatore: General Pharma Solutions S.p.a. - Vasil Levski St. 103 - 1000 Sofia. Confezione: Reactine «5 mg + 120 mg compresse a rilascio prolungato» 14 compresse - Codice A.I.C. n. 045460019 (in base 10) 1CCBKM (in base 32). Forma farmaceutica : compresse a rilascio prolungato: Ogni compressa contiene: principio attivo: cetirizina dicloridrato 5 mg;
pseudoefedrina cloridrato 120 mg;
eccipienti del primo strato: idrossipropilmetilcellulosa, cellulosa microcristallina, silice colloidale anidra, magnesio stearato;
eccipienti del secondo strato: lattosio monoidrato, cellulosa microcristallina, sodio crosscaramelloso, silice colloidale anidra, magnesio stearato;
eccipienti del rivestimento: Opadry® Y-1-7000 bianco (Idrossipropilmetilcellulosa (E 464), diossido di titanio (E 171), macrogol 400). Indicazioni terapeutiche: Reactine e' indicato nel trattamento sintomatico a breve termine delle riniti allergiche stagionali e/o perenni con congestione ed ipersecrezione nasale, prurito nasale e/o oculare, starnutazione e lacrimazione. Officine di confezionamento secondario XPO Supply Chain Pharma Italy - S.p.a., via Annendola n. 1 - 20090 Caleppio di Settala (Milano);
S.C.F. S.n.c. Di Giovenzana...
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