COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Triatec» (20A01789)
Estratto determina IP n. 142 del 25 febbraio 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale DELIX PROTECT 10 mg tabletten 100 tabletten dalla Germania con numero di autorizzazione 50295,00,00, intestato alla societa' Sanofi-Aventis Deutschland GmbH Bruningstrasse 50 65926 Frankfurt Am Main Germany e prodotto da Sanofi S.p.a viale Luigi Bodio 37/B 20158 Milano, Sanofi-Aventis Deutschland GmbH Bruningstrasse 60 65926 Frankfurt Am Main Germany, S.C. Zentiva S.A. B- Dul Theodor Pallady nr. 50 Sector 3 032266 Bucarest, Sanofi S.p.a. (BS2) strada statale n. 17 km. 22 67019 Scoppito (L'Aquila,) Delpharm Dijon (BS1) 6 Boulevard de l'Europe 218000 Quetigny 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: TRIATEC «10 mg compresse» 28 compresse divisibili. Codice A.I.C. n. 046979023 (in base 10) 1DTPYH (in base 32). Forma farmaceutica: compressa. Composizione: ogni compressa contiene. Principio attivo: ramipril 10 mg. Eccipienti: ipromellosa, amido di mais pregelatinizzato, cellulosa microcristallina, sodio stearilfumarato. Officine di confezionamento secondario: S.C.F. S.r.l. - via F. Barbarossa, 7 - 26824 Cavenago D'Adda (LO);
PHARM@IDEA S.r.l - via del Commercio, 5 - 25039 Travagliato (BS). Classificazione ai fini della rimborsabilita' Confezione: TRIATEC «10 mg compresse» 28 compresse divisibili. Codice A.I.C. n. 046979023. 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...
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