COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Yasmin» (19A03755)
Estratto determina IP n. 383 del 29 maggio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale YASMIN «0,03 mg/3 mg filmdrasjerte tabletter» 3×21 tabletter dalla Norvegia con numero di autorizzazione MT-2000-02880, intestato alla societa' Bayer AB e prodotto da Bayer AG 13342 Berlino - Germania, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.r.l., con sede legale in via Lambretta n. 2 - 20090 Segrate (MI). Confezione: YASMIN «0,03 mg/3 mg compresse rivestite con film» 21 compresse in blister polivinilecloruro/AL. Codice A.I.C.: 043013046 (in base 10) 190NXQ (in base 32). Forma farmaceutica: compressa rivestita. Composizione: una compressa rivestita contiene: principio attivo: 3 milligrammi di drospirenone e 0,030 milligrammi di etinilestradiolo;
eccipienti: lattosio monoidrato, amido di mais, amido di mais pregelatinizzato, povidone K25, magnesio stearato, ipromellosa, macrogol 6.000, talco, titanio diossido (E171), ferro ossido giallo (E172). Officine di confezionamento secondario: De Salute S.r.l., via Biasini n. 26 - 26015 Soresina (CR);
Pharma Partners S.r.l., via E. Strobino n. 55/57 - 59100 Prato. Classificazione ai fini della rimborsabilita' Confezione: YASMIN «0,03 mg/3 mg compresse rivestite con film» 21 compresse in blister polivinilecloruro/AL. Codice A.I.C.: 043013046. Classe di rimborsabilita': C(nn). La confezione sopradescritta e' collocata in «apposita sezione» della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non...
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