COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Betabioptal» (19A03131)
Estratto determina IP n. 162 dell'11 marzo 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale BETABIOPTAL «2 mg/5 mg/ml Picaturi Oftalmice, Suspensie» flacone 5 ml dalla Romania con numero di autorizzazione 6969/2006/01, intestato alla societa' Thea Farma S.p.a. e prodotto da Farmila - Thea farmaceutici S.p.a., con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farmed S.r.l., con sede legale in via Cavallerizza a Chiaia n. 8 - 80121 Napoli. Confezione: «Betabioptal» 0,2% + 0,5% collirio, sospensione flacone 5 ml, codice A.I.C. n. 047456013 (in base 10), 1F87SF(in base 32). Forma farmaceutica: collirio, sospensione. Composizione: 100 ml di collirio contengono: principio attivo: betametasone 0,2 g e cloramfenicolo 0,5;
eccipienti: macrogol 300, macrogol 1500, macrogol 4000, acido borico, sodio borato, polisorbato 80, ipromellosa, tiomersale, acqua depurata. Officine di confezionamento secondario: De Salute S.r.l., via Biasini n. 26 - 26015 Soresina (Cremona);
XPO Supply Chain Pharma Italy S.p.a., via Amendola n. 1 - 20090 Caleppio di Settala (Milano);
Falorni S.r.l., via Provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (Pistoia). Classificazione ai fini della rimborsabilita' Confezione: «Betabioptal» 0,2% + 0,5% collirio, sospensione flacone 5 ml, codice A.I.C. n. 047456013, 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...
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