COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Azalia» (19A03120)
Estratto determina IP n. 289 del 16 aprile 2019 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale AZALIA «75 mcg comprimidos revestidos por pelicula» 84 comprimidos dal Portogallo con numero di autorizzazione 5317508, intestato alla societa' Gedeon Ritcher PLC e prodotto da Gedeon Ritcher PLC, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Programmi Sanitari Integrati S.r.l. con sede legale in via Giovanni Lanza, 3 - 20100 Milano. Confezione: AZALIA «75 microgrammi compresse rivestite con film» 1×28 compresse in blister PVC/PVDC/AL;
codice A.I.C. n.: 047389010 (in base 10) 1F66BL (in base 32);
forma farmaceutica: compressa;
composizione: una compressa 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 una 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 1 etichetta calendario adesiva da applicare sul blister al momento dell'utilizzo. Officine di confezionamento secondario: STM Pharma Pro S.r.l. Strada provinciale pianura 2 - 80078 Pozzuoli (NA);
Prespack, Jacek Karonski Poland, Skorzewo, ul. Sadowa 38. 60-185;
Pharm@idea S.r.l., via del Commercio, 5 - 25039 Travagliato (BS). Classificazione ai fini della rimborsabilita' Confezione: AZALIA «75 microgrammi compresse rivestite con film» 1×28 compresse in blister...
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