COMUNICATO - Importazione parallela del medicinale per uso umano «Yaz». (14A01457)
Estratto determinazione V &
A IP n. 251 del 4 febbraio 2014 E' autorizzata l'importazione parallela del medicinale YAZ 0,02 mg/3 mg 28 comprimate filmate (1×28 comprimate) dalla Romania con numero di autorizzazione 883/2008/01 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione: importatore: Medifarm S.r.l., via Tiburtina n. 1166/1168 - 00156 Roma;
confezione: «Yaz» 0,02 mg/3 mg compresse rivestite con film 28 compresse in blister PVC/AL;
codice A.I.C.: 042937019 (in base 10), 18YBPV (in base 32);
forma farmaceutica: compresse rivestite;
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;
rivestimento: ipromellosa 6cp, talco, titanio diossido (E 171), ferro ossido rosso (E 172);
compresse placebo, bianche: queste compresse non contengono principi attivi;
eccipienti: nucleo: lattosio monoidrato, amido di mais, magnesio stearato, povidone K 25;
rivestimento: ipromellosa 6cP, talco, titanio diossido (E 171). Indicazioni terapeutiche: «Yaz» e' una pillola contraccettiva e serve per prevenire la gravidanza. Confezionamento secondario: e' autorizzato il riconfezionamento secondario presso l'officina Mediwin Limited, Unit 12-13 Martello Enterprise Centre Courtwick Lane - Littlehampton West Sussex BN17 7PA, Regno Unito. Classificazione ai fini della...
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