COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Cerazette» (20A00002)
Estratto determina IP n. 879 dell'11 dicembre 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione. E' autorizzata l'importazione parallela del medicinale CERAZETTE «75 microgram filmcoated tablets» 3 x 28 tablets dal Regno Unito con numero di autorizzazione PL 00025/0562, intestato alla societa' Organon Laboratories Limited (UK) e prodotto da NV Organon (NL), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: New Pharmashop S.r.l. con sede legale in Cis Di Nola Isola 1, Torre 1, int. 120, 80035 Nola - NA. Confezione: CERAZETTE «0,1 mg + 0,02 mg compresse rivestite» 21 compresse. Codice A.I.C. n. 048159014 (in base 10) 1FXQ96 (in base 32). Forma farmaceutica: compressa rivestita. Composizione: una compressa rivestita contiene: principio attivo: 75 microgrammi desogestrel;
eccipienti: silice colloidale anidra;
tutto-rac-α-tocoferolo;
amido di mais;
povidone;
acido stearico;
ipromellosa;
macrogol 400;
talco;
titanio diossido (E171);
lattosio monoidrato (vedere anche «Cerazette contiene lattosio», al paragrafo 2). Officine di confezionamento secondario: Pharma Partners S.r.l. - via E. Strobino n. 55/57 - 59100 Prato (PO);
Pharm@idea S.r.l. - via del Commercio n. 5 - 25039 Travagliato (BS);
S.C.F. S.r.l. - via F. Barbarossa n. 7 - 26824 Cavenago D'Adda - (LO);
De Salute S.r.l. - via Biasini n. 26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: CERAZETTE «0,1 mg + 0,02 mg compresse rivestite» 21 compresse. Codice A.I.C. n. 048159014. 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 ancora valutati ai fini della...
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