COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Azalia» (18A05095)
Estratto determina IP n. 540 del 12 luglio 2018 E' autorizzata l'importazione parallela del medicinale AZALIA 75 micrograms comprimidos, 84 comprimidos (3X28) 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 determinazione. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta n. 2 - 20090 Segrate (MI). Confezione: «Azalia» - «75 microgrammi compresse rivestite con film» - 1x28 compresse in blister PVC/PVDC/AL Codice A.I.C. : 046102012 (in base 10) 1CYXHW (in base 32) Forma farmaceutica: compressa rivestita con film Composizione: una compressa rivestita con film contiene: Principi attivi: 75 microgrammi di Desogestrel;
Eccipienti: Nucleo delle compresse: Lattosio monoidrato, Amido di patate, Povidone K-30, Silice colloidale anidra, Acido stearico, ^-Tocoferolo tutto racemico Rivestimento: Polivinilalcol;
Diossido di titanio E171;
Macrogol 3000;
Talco. Indicazione terapeutiche: contraccezione 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 al momento dell'utilizzo. Officine di confezionamento secondario: De Salute S.r.l., via Biasini n. 26 - 26015 Soresina Cremona;
CIT S.r.l., via Primo Villa n...
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