COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Pevaryl» (20A03150)
Estratto determina IP n. 331 dell'8 giugno 2020 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale PEVARYL 1% CREMA, dalla Grecia con numero di autorizzazione 40436/08/9-11-2009, intestato alla societa' Janssen-Jilag farmaceutica A.E.B.E. Leof. Eirines 56,151 21, Peyki Greece e prodotto da Janseen pharmaceutica N. V. Beerse Belgium Turnhoutseweg 30, 2340 Beerse Belgium, AMAP ABE 49 km Ethnikis Odoy Athinon Lamias Aylonas Greece, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Gekofar S.r.l. con sede legale in Piazza Duomo, 16 20122 Milano MI. Confezione: Pevaryl «1% crema» tubo da 30 g. Codice A.I.C.: 043556024 (in base 10) 19K75S (in base 32). Forma farmaceutica: crema. Composizione: 100 g di crema contengono Principio attivo: econazolo nitrato 1,0 g Eccipienti: tefose 63 (pegoxol 7 stearato), labrafil M 1944 CS (peglicole 5 oleato), paraffina liquida, butilidrossianisolo, profumo n. 4074, acido benzoico, acqua depurata Avvertenza da aggiungere al foglio illustrativo relativa agli eccipienti ad effetto noto: Informazioni importanti su alcuni eccipienti di Pevaryl: questo medicinale contiene butilidrossianisolo che puo' causare reazioni sulla pelle localizzate (ad es. dermatite da contatto) o irritazione agli occhi e alle mucose. Officine di confezionamento secondario: XPO Supply Chain Pharma Italy S.p.a., Via Amendola, 1, 20090 Caleppio di Settala (MI);
S.C.F. S.r.l., Via F. Barbarossa, 7, 26824 Cavenago D'Adda - LO;
De Salute S.r.l., Via Biasini, 26, 26015 Soresina (CR)...
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