COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Femara» (17A01932)
Estratto determina IP n. 153 del 21 febbraio 2017 E' autorizzata l'importazione parallela del medicinale FEMARA 2,5 mg filmtabletta 100 filmtabletta PVC/PE/PVDC/Al dall'Ungheria con numero di autorizzazione OGYI-T-05712/02 con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determinazione. Importatore: Pricetag Spa con sede legale in Vasil Levski St. 103 - 1000 Sofia. Confezione: Femara «2,5 mg compresse rivestite con film» 30 compresse in blister PVC/PE/PVDC/Al;
codice A.I.C.: 044907018 (in base 10) 1BUGJB (in base 32). Forma farmaceutica: compresse rivestite con film. Composizione: ogni compressa rivestita con film contiene: principio attivo: letrozolo 2,5 mg;
eccipienti: nucleo: lattosio monoidrato, cellulosa microcristallina, amido di mais, sodio carbossimetilamido (tipo A), magnesio stearato, silice colloidale anidra;
rivestimento: ipromellosa, talco, Macrogol 8000, biossido di titanio (E171), ossido di ferro giallo (E172). Indicazioni terapeutiche: trattamento adiuvante del carcinoma mammario invasivo in fase precoce in donne in postmenopausa con stato recettoriale ormonale positivo;
trattamento adiuvante del carcinoma mammario ormonosensibile invasivo in donne in postmenopausa dopo trattamento adiuvante standard con tamoxifene della durata di 5 anni;
trattamento di prima linea del carcinoma mammario ormonosensibile, in fase avanzata, in donne in postmenopausa;
trattamento del carcinoma mammario in fase avanzata in donne in postmenopausa naturale o artificialmente indotta, dopo ripresa o progressione della malattia che siano state trattate in precedenza con antiestrogeni;
trattamento neoadiuvante in donne in postmenopausa con carcinoma mammario con stato recettoriale ormonale positivo, HER-2 negativo in cui la chemioterapia non e' possibile e un immediato intervento...
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