COMUNICATO - Importazione parallela del medicinale per uso umano «Pevaryl». (14A09675)
Estratto determina V &
A IP n. 2405 del 19 novembre 2014 E' autorizzata l'importazione parallela del medicinale PEVARYL cream 1% WW BTx30g dalla Grecia, con numero di autorizzazione 19821/16-06-1993 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Gekofar S.r.l., Piazza Duomo, 16 - 20122 Milano;
Confezione: Pevaryl «1% crema» Tubo da 30 g. Codice AIC: 043556012 (in base 10) 19K75D (in base 32). Forma farmaceutica: crema. Composizione: 100 g di crema contengono. Principio Attivo: econazolo nitrato g 1,0;
Eccipienti: miscela di esteri dell'acido stearico con glicoli;
miscela di acidi grassi con glicole polietilenico;
olio di vaselina;
butilidrossianisolo;
profumo;
acido benzoico;
acqua depurata. Indicazioni terapeutiche: Il prodotto e' indicato nella terapia di: micosi cutanee causate da dermatofiti, lieviti o muffe ed infezioni sostenute da batteri Gram-positivi;
micosi del condotto uditivo (limitatamente alla forma emulsione) e delle unghie;
Pityriasis Versicolor. Confezionamento secondario E' autorizzato il confezionamento secondario presso le officine Fiege Logistics Italia S.p.A., Via Amendola 1, 20090 Caleppio di Settala (MI);
S.C.F. S.n. c. Di Giovenzana Roberto e Pelizzola Mirko Claudio Via F. Barbarossa, 7 - 26824 Cavenago D'Adda - LO;
CIT S.r.l., Via Primo Villa 17, 20875 Burago di Molgora (MB);
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