COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Clody» (20A00228)
Estratto determina AAM/PPA n. 1020 del 13 dicembre 2019 Si autorizza la seguente variazione: VN2/2019/213, Tipo II C.I.4.z). Si modificano i paragrafi 2, 4.2, 4.4, 4.5, 4.7 e 4.8 del riassunto delle caratteristiche del prodotto, le corrispondenti sezioni del foglio illustrativo e la sezione 2 del confezionamento secondario relativamente al dosaggio «300 mg/10 ml concentrato per soluzione per infusione». Si modificano i paragrafi 2, 4.2, 4.4, 4.7 e 4.8 del riassunto delle caratteristiche del prodotto, le corrispondenti sezioni del foglio illustrativo e la sezione 2 del confezionamento secondario relativamente ai dosaggi «100 mg/3,3 ml soluzione iniettabile per uso intramuscolare con lidocaina 1%» e «200 mg/4ml soluzione iniettabile per uso intramuscolare con lidocaina 1%». La suddetta variazione e' relativa al medicinale CLODY nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura nazionale. A.I.C. n.: 034294013 - «100 mg/3,3 ml soluzione iniettabile per uso intramuscolare con lidocaina 1%» 6 fiale 3,3 ml;
034294025 - «100 mg/3,3 ml soluzione iniettabile per uso intramuscolare con lidocaina 1%» 12 fiale 3,3 ml;
034294037 - «300 mg/10 ml concentrato per soluzione per infusione» 6 fiale;
034294102 - «200 mg/4 ml soluzione iniettabile per uso intramuscolare con lidocaina 1%» 3 fiale da 4 ml;
034294114 - «200 mg/4 ml soluzione iniettabile per uso intramuscolare con lidocaina 1%» 6 fiale da 4 ml. Gli stampati corretti ed approvati sono allegati alla determina, di cui al presente estratto. Codice pratica: VN2/2019/213. Titolare A.I.C.: Promedica S.r.l (codice fiscale 01697370342). Stampati 1. Il titolare dell'autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente determina al riassunto delle caratteristiche del prodotto;
entro e non oltre i sei mesi dalla medesima data al foglio illustrativo e all'etichettatura. 2. In...
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