COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Terbinafina Tecnigen» (15A04810)
Estratto determina n. 705/2015 dell'8 giugno 2015 Medicinale: TERBINAFINA TECNIGEN. Titolare AIC: Premium Pharma, S.L. - Avda. de Bruselas, 13, 3° D. Edificio America - Poligono Arroyo de la Vega, Alcobendas, 28108 Madrid - Spagna. Confezione: "250 mg compressa" 8 compresse. AIC n. 042855015 (in base 10) 18VUM7 (in base 32). Forma farmaceutica: Compressa. Composizione: Ogni compressa contiene: Principio attivo: terbinafina cloridrato 281,25 mg (pari a 250 mg di terbinafina). Eccipienti: Cellulosa microcristallina PH101 ;
Ipromellosa;
Croscarmellosa sodica;
Silice colloidale anidra;
Magnesio stearato;
Produzione principio attivo: Hetero Labs Limited, Survey No. 10, Gaddapotharam Village, Jinnaram Mandal, 502319 Medak District, Andhra Pradesh, India. Produzione, confezionamento primario e secondario, controllo e rilascio dei lotti: West Pharma - Produções de Especialidades Farmacêuticas S.A., Rua João de Deus n. 11, Venda Nova, 2700-486 Amadora, Portogallo. Atlantic Pharma - Produções Farmacêuticas S.A., Rua da Tapada Grande n. 2, Abrunheira, 2710-089 Sintra, Portogallo. Indicazioni terapeutiche: Onicomicosi (infezioni micotiche delle unghie) causate da funghi dermatofiti. Tinea capitis. Infezioni micotiche cutanee da dermatofiti (Tinea corporis, Tinea cruris, Tinea pedis) e infezioni cutanee da lieviti, sostenute dal genere Candida (es.: Candida albicans) per le quali la terapia orale e' considerata appropriata in ragione della loro localizzazione, severita' od estensione dell'infezione. Nota: A differenza delle formulazioni topiche di terbinafina, le compresse di terbinafina somministrate per via orale non sono efficaci contro...
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