COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Yaz» (19A03132)
Estratto determina IP n. 165 dell'11 marzo 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione E' autorizzata l'importazione parallela del medicinale YAZ, 0,02 mg + 3 mg, Tabletki Powleka.ne, 28 Tabletek dalla Polonia con numero di autorizzazione 14780, intestato alla societa' Bayer AG e prodotto da Bayer AG e da Bayer Weimar GmbH und Co. KG, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farmed S.r.l. con sede legale in via Cavallerizza a Chiaia n. 8, 80121 Napoli. Confezione: YAZ «0.02 mg/3 mg compresse rivestite con film» 28 compresse in blister PVC/AL. Codice AIC: 044914024 (in base 10) 1BUPC8(in base 32). Forma farmaceutica: compresse rivestite. Composizione: ogni compressa attiva rivestita con film rosa chiaro contiene: Principio attivo: 0,020 milligrammi di etinilestradiolo (come clatrato di betadestrina) e 3 milligrammi di drospirenone. Eccipienti: compressa rivestita con film attiva (rosa chiaro). Nucleo della compressa: lattosio monoidrato, amido di mais, magnesio stearato (E470b), rivestimento con film della compressa: ipromellosa (E464), talco (E553b), titanio diossido (E171), ferro ossido rosso (E172). Compressa rivestita con film placebo (bianca). Nucleo della compressa: lattosio monoidrato, Cellulosa microcristallina, magnesio stearato (E470b), rivestimento con film della compressa: ipromellosa (E464), talco (E553b), titanio diossido (E171). Officine di confezionamento secondario Pharma Partners S.r.l., via E. Strobino nn. 55/57, 59100 Prato;
De Salute S.r.l., via Biasini n. 26, 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: YAZ «0.02 mg/3 mg compresse rivestite con film» 28 compresse in blister PVC/AL. Codice AIC: 044914024. Classe di rimborsabilita': C(nn). La confezione...
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