COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Yaz» (17A01454)
Estratto determina n. 51 del 7 febbraio 2017 E' autorizzata l'importazione parallela del medicinale YAZ 24+4 0,02 mg/3 mg filmomhulde tabletten 3X28 tab. dall'Olanda con numero di autorizzazione RVG 33842, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci alla data di entrata in vigore della presente determinazione: Importatore: Gekofar S.r.l. con sede legale in Piazza Duomo, 16 - 20122 Milano;
Confezione: YAZ «0,02 mg/3 mg compresse rivestite con film» 28 compresse in blister PVC/Al Codice AIC: 045103013 (in base 10) 1C0FX5 (in base 32) Forma farmaceutica: compresse rivestite con film Compresse attive, rosa chiaro: Principi attivi: Etinilestradiolo 0,020 mg (come clatrato di beta destrina);
Drospirenone 3 mg;
Eccipienti: Nucleo: lattosio monoidrato, amido di mais, magnesio stearato (E470b). Rivestimento: Ipromellosa (E464), talco (E553b), titanio diossido (E 171), ferro ossido rosso (E 172);
Compresse placebo, bianche: Queste compresse non contengono principi attivi. Eccipienti: Nucleo : lattosio monoidrato, magnesio stearato (E470b), cellulosa microcristallina. Rivestimento: Ipromellosa (E464), talco (E553b), titanio diossido (E 171). Indicazioni terapeutiche: «Yaz» e' una pillola contraccettiva e serve per prevenire la gravidanza. Officine di confezionamento secondario S.C.F. S.n.c. Di Giovenzana Roberto e Pelizzola Mirko Claudio Via F. Barbarossa, 7 - 26824 Cavenago D'Adda -...
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