COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Azalia» (19A04563)
Estratto determina IP n. 410 dell'11 giugno 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del AZALIA 75 microgramas comprimidos revestidos por pelicula 3*28 comprimidos dal Portogallo con numero di autorizzazione 5317508, intestato alla societa' Gedeon Richter PLC e prodotto da Gedeon Richter PLC, 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: AZALIA «75 microgrammi compresse rivestite con film 1×28 compresse in blister PVC/PVDC/AL - codice A.I.C. n. 047520010 (in base 10) 1FB68B (in base 32). Forma farmaceutica: compressa rivestita con film. Composizione: una compressa rivestita con film contiene: principio attivo: 75 microgrammi di desogestrel;
eccipienti: nucleo delle compresse: lattosio monoidrato, amido di patate, povidone K-30, silice colloidale anidra, acido stearico, a-tocoferolo tutto racemico;
rivestimento: polivinilalcol, diossido di titanio E171, macrogol 3000, talco. Descrizione dell'aspetto di AZALIA e contenuto della confezione: AZALIA e' una compressa rivestita con film, bianca o biancastra, rotonda, biconvessa, di circa 5,5 mm di diametro, con il segno «D» su un lato e «75» sull'altro lato. AZALIA compresse rivestite con film e' confezionato in un blister costituito da PVC/PVDC trasparente, rigido, foglio d'alluminio. Ogni blister e' posto in un sacchetto in alluminio laminato. I blister nei sacchetti sono confezionati in una scatola di cartone ripiegato insieme al foglietto illustrativo, un piccolo astuccio per riporre il blister ed una etichetta calendario adesiva da applicare sul blister al momento dell'utilizzo. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.a., via Amendola n. 1 - 20090 Caleppio di Settala (MI);
Falorni S.r.l., via Provinciale Lucchese, localita' Masotti - 51030 Serravalle Pistoiese (PT);
De Salute S.r.l., via Biasini n. 26 - 26015 Soresina (CR). Classificazione ai fini della rimborsabilita' Confezione: AZALIA «75...
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