COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Letrozolo Tecnimede» (13A06204)
Estratto determinazione n. 626/2013 del 9 luglio 2013 Medicinale: LETROZOLO TECNIMEDE Titolare AIC: Tecnimede Sociedade Tecnico-Medicinal S.A. - Rua da Tapada Grande nº 2, Abrunheira - 2710-089 Sintra - Portogallo Confezione: "2,5 mg compresse rivestite con film" 30 compresse in blister AL/PVDC/PVC/PE/PVDC - AIC n. 042723015/M (in base 10) 18RTQ7 (in base 32) Forma farmaceutica: Compressa rivestita con film Composizione: Ogni compressa rivestita con film contiene: Principio attivo: 2,5 mg di letrozolo Eccipienti: Nucleo della compressa: Lattosio monoidrato Cellulosa microcristallina Amido di mais Silice anidra colloidale Sodio amido glicolato (Tipo A) Magnesio stearato Rivestimento della compressa: Alcol polivinilico Talco Titanio diossido (E171) Macrogol 3350 Giallo di chinolina lacca di alluminio (E104) Ferro ossido rosso (E172) Ferro ossido nero (E172) (Opadry II 85F32444 giallo) Produttori del principio attivo: Natco Pharma Limited - Chemical Division - Mekaguda Village, Kothur Mandal - 509 223 Mehaboob Nagar - India Ind-Swift Laboratories Limited - Village Bhagwanpur, Barwala Road - District SAS Nagar (Mohali) - 140507 Derabassi, Patiala - India Produttore del prodotto finito: Produzione, confezionamento primario e secondario, controllo di qualita', rilascio dei lotti West Pharma - Produções de Especialidades Farmacêuticas S.A. - Rua João de Deus, N.º 11, Venda Nova - 2700 Amadora, Portogallo Indicazioni terapeutiche: Trattamento adiuvante del carcinoma mammario invasivo in fase precoce in donne in post-menopausa con stato recettoriale ormonale positivo. Trattamento adiuvante prolungato del carcinoma mammario ormonosensibile invasivo in donne in post-menopausa 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 post- menopausa. Trattamento del carcinoma mammario in fase avanzata in donne in post-menopausa naturale o artificialmente indotta, dopo ripresa o progressione della malattia, che siano state trattate in precedenza con antiestrogeni. Trattamento...
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