COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Triatec» (18A07955)
Estratto determina IP n. 782 del 27 novembre 2018 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale TRIATEC COMPOSTO FORTE 5 mg/25 mg (4x14) dal Portogallo con numero di autorizzazione 5907183, intestato alla societa' Sanofi Produtos Farmaceuticos LDA e prodotto da Zentiva S.A. e da Sanofi S.p.a. (Scoppito - IT), 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 HCT «5 mg + 25 mg compresse» 14 compresse Codice A.I.C.: 046979011 (in base 10) 1DTPY3 (in base 32) Forma Farmaceutica: compresse. Ogni compressa divisibile contiene: principio attivo: Ramipril 5 mg e Idroclorotiazide 25 mg. Eccipienti: ipromellosa, amido di mais pregelatinizzato, cellulosa microcristallina ,sodio stearilfumarato. Officine di confezionamento secondario De Salute S.r.l. via Biasini n. 26 - 26015 Soresina (CR) 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 Classificazione ai fini della rimborsabilita' Confezione: Triatec HCT «5 mg + 25 mg compresse» 14 compresse Codice A.I.C. n. 046979011 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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