COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Arlevert» (19A05999)
Estratto determina IP n. 507 dell'8 luglio 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' revocato il provvedimento di diniego n. 295 del 16 aprile 2019 ed e' contestualmente autorizzata l'importazione parallela del medicinale ARLEVERT 20mg/40mg tabletten, 100 tabletten dalla Germania con numero di autorizzazione 6147944,00,00, intestato alla societa' Hennig Arzneimittel GmbH &
Co. KG e prodotto da Hennig Arzneimittel GmbH &
Co. KG, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Pricetag Spa con sede legale in via Vasil Levski 103 1000 Sofia. Confezione: ARLEVERT «20 mg/40 mg compresse» 20 compresse in blister PVC/PVDC/AL - Codice A.I.C. n.: 046767024 (in base 10), 1DM6XJ (in base 32). Forma farmaceutica: compressa. Composizione: una compressa contiene: principio attivo: cinnarizina 20 mg e dimenidrinato 40 mg;
eccipienti: cellulosa microcristallina, amido di mais, talco, ipromellosa, silice anidra colloidale, magnesio stearato e sodio croscarmellosa. Officine di confezionamento secondario: Falorni S.r.l., via Provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (Pistoia);
S.C.F. S.r.l., via F. Barbarossa, 7 - 26824 Cavenago d'Adda (Lodi);
Xpo Supply Chain Pharma Italy S.p.a., via Amendola, 1 - 20090 Caleppio di Settala (Milano);
Pricetag Ead Business Center Serdica, 2E Ivan Geshov blvd. 1000 Sofia (Bulgaria). Classificazione ai fini della rimborsabilita' Confezione: ARLEVERT «20 mg/40 mg compresse» 20 compresse in blister PVC/PVDC/AL - Codice A.I.C. n.: 046767024;
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...
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