COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura nazionale, del medicinale per uso umano «Ciprofloxacina Bioindustria L.I.M.», con conseguente modifica stampati. (17A07824)
Estratto determina AAM/PPA n. 996/2017 del 13 ottobre 2017 L'autorizzazione all'immissione in commercio del medicinale: CIPROFLOXACINA BIOINDUSTRIA L.I.M. Codice A.I.C.: 038279. Confezioni: 038279016 - «200 mg/100 ml soluzione per infusione» 5 flaconi da 100 ml;
038279028 - «200 mg/100 ml soluzione per infusione» 10 flaconi da 100 ml;
038279030 - «200 mg/100 ml soluzione per infusione» 25 flaconi da 100 ml;
038279042 - «400 mg/200 ml soluzione per infusione» 5 flaconi da 200 ml;
038279055 - «400 mg/200 ml soluzione per infusione» 10 flaconi da 200 ml;
038279067 - «400 mg/200 ml soluzione per infusione» 25 flaconi da 200 ml. Titolare A.I.C.: Bioindustria Laboratorio Italiano Medicinali S.p.a. Procedura: Nazionale, con scadenza il 30 marzo 2015 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 mentre per il Foglio illustrativo ed etichettatura entro e non oltre sei mesi dalla pubblicazione nella Gazzetta Ufficiale della Repubblica italiana della presente determinazione. In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni e integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella provincia di...
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