COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Micotef». (13A07903)
Estratto determinazione FV n. 219/2013 del 7 agosto 2013 Medicinale: MICOTEF Confezioni: 023491 172 - crema cutanea 2%, tubo 30 g 023491 160 - soluzione vaginale 0,2%, 5 contenitori monodose 150 ml 023491 133 - gel orale 2%, tubo da 40 g 023491 083 - ovuli vaginali 150 mg, 15 ovuli vaginali 023491 057 - crema vaginale 2%, tubo da 30 g Titolare AIC: Teofarma S.r.l. Procedura nazionale Con scadenza il 5 marzo 2010 e' rinnovata, con validita' illimitata, l'autorizzazione all'immissione in commercio previa modifica del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e dell'Etichettatura ed a condizione che, alla data di entrata in vigore della presente determinazione, i requisiti di qualita', sicurezza ed efficacia siano ancora presenti. Le modifiche devono essere apportate immediatamente per il Riassunto delle Caratteristiche del Prodotto, per il Foglio Illustrativo ed Etichettatura entro 90 giorni dall'entrata in vigore della determinazione. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e s.m.i. il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai...
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