COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Trosyd». (15A05246)
Estratto determina V&A n. 1105/2015 del 9 giugno 2015 Descrizione del medicinale e attribuzione numero A.I.C.: e' autorizzata l'immissione in commercio del medicinale TROSYD, anche nella forma e confezione: «1% spray cutaneo, soluzione» contenitore multidose da 30 g con pompa spray, alle condizioni e con le specificazioni di seguito indicate, purche' siano efficaci alla data di entrata in vigore della presente determinazione. Titolare A.I.C.: Giuliani S.p.a., con sede legale e domicilio fiscale in via Palagi n. 2 - 20129 Milano (Italia), codice fiscale n. 00752450155. Confezione: «1% spray cutaneo, soluzione» contenitore multidose da 30 g con pompa spray, A.I.C. n. 025647140 (in base 10), 0SGQ14 (in base 32), forma farmaceutica: spray cutaneo, soluzione. Validita' prodotto integro: due anni dalla data di fabbricazione. Produttore del principio attivo: Erregierre S.p.a., via Francesco Baracca n. 19 - 24060 San Paolo d'Argon (Bergamo) - Italia. Produttore del prodotto finito: Zellaerosol GmbH, Wiesenstrasse 13 D-79669 Zell in Wiesental Germania (tutte le fasi). Composizione: 1 g spray cutaneo, soluzione contiene: principio attivo: tioconazolo 10 mg;
eccipienti: isopropilmiristato, alcool isopropilico. Indicazioni terapeutiche: «Trosyd» 1% spray cutaneo, soluzione. Dermatomicosi sostenute da dermatofiti, lieviti ed altri miceti sensibili al tioconazolo. Per la concomitante attivita' antimicotica e antibatterica, e' particolarmente indicato nelle infezioni cutanee miste. Classificazione ai fini della rimborsabilita' Confezione: A.I.C. n. 025647140 - «1% spray cutaneo, soluzione» contenitore multidose da 30 g con pompa spray, classe di rimborsabilita': «C bis». Classificazione ai fini della fornitura Confezione: A.I.C. n. 025647140 - «1% spray cutaneo, soluzione» contenitore multidose da 30 g con pompa spray - OTC: medicinale non soggetto a prescrizione medica, da banco. Stampati Le confezioni del medicinale devono essere poste in commercio con etichette e fogli illustrativi conformi al testo allegato alla determinazione, di cui al presente estratto. E' approvato il riassunto delle caratteristiche del prodotto allegato alla determinazione, di cui al presente estratto. In ottemperanza all'art. 80, commi 1 e 3 del decreto legislativo 24 aprile 2006, n. 219, e successive...
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