COMUNICATO - Autorizzazione dell'importazione parallela del medicinale per uso umano «Norlevo» (19A05269)
Estratto determina IP n. 540 del 23 luglio 2019 E' autorizzata l'importazione parallela del medicinale NORLEVO 1,5 mg comprime' - 1 comprime' dalla Francia con numero di autorizzazione 3400936413726, intestato alla societa' Laboratoire HRA Pharma (FR) e prodotto da Cenexi - Onsy (FR) e da Delpharm Lille S.a.s. - Lys Lez Lannoy (FR), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: New Pharmashop S.r.l., con sede legale in CIS di Nola isola 1, torre 1, int. 120 - 80035 Nola (Napoli). Confezione: «Norlevo» 1,5 mg compresse 1 compressa in blister PVC/PE/PVDC/AL, codice A.I.C. n. 047813011 (in base 10), 1FM4DM(in base 32). Forma farmaceutica: compressa. Composizione: una compressa contiene: principio attivo: 1,5 mg di levonorgestrel;
eccipienti: lattosio monoidrato, amido di mais, povidone, silice colloidale anidra, magnesio stearato. Officine di confezionamento secondario: Pharm@Idea S.r.l., via del Commercio n. 5 - 25039 Travagliato (Brescia);
Pharma Partners S.r.l., via E. Strobino n. 55/57 - 59100 Prato;
S.C.F. S.r.l., via F. Barbarossa n. 7 - 26824 Cavenago D'Adda (Lodi). Classificazione ai fini della rimborsabilita' Confezione: «Norlevo» 1,5 mg compresse 1 compressa in blister PVC/PE/PVDC/AL, codice A.I.C. n. 047813011, 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 rimborsabilita', denominata classe «C (nn)», nelle more della presentazione da parte del titolare dell'AIP di una eventuale domanda di diversa classificazione...
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