COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Glazidim». (15A03364)
Estratto determinazione V&A n. 672/2015 del 2 aprile 2015 Autorizzazione della variazione relativamente al GLAZIDIM. E' autorizzata la seguente variazione: modifica dei paragrafi 4.2, 4.3, 4.8, 5.1, 6.6 e corrispondenti sezioni del Foglio Illustrativo. Aggiornamento del QDR template relativamente al medicinale GLAZIDIM, nelle forme e confezioni: 025212010 - «250 mg/1 ml polvere + solvente per soluzione iniettabile per uso intramuscolare» 1 flacone polvere + fiala solvente 1 ml;
025212022 - «500 mg/1,5 ml polvere e solvente per soluzione iniettabile per uso intramuscolare» 1 flaconcino di polvere + fiala solvente da 1,5 ml;
025212034 - «1 g/3 ml polvere e solvente per soluzione iniettabile per uso intramuscolare» 1 flaconcino polvere + fiala solvente da 3 ml;
025212046 - «1 g/10 ml polvere + solvente per soluzione iniettabile per uso endovenoso» 1 flacone polvere 1 g + fiala solvente 10 ml;
025212059 - «2 g polvere per soluzione per infusione» 1 flaconcino di polvere;
025212073 - «1 g polvere per soluzione per infusione» 1 flacone 1 g con dispositivo Monovial;
025212085 - «2 g polvere per soluzione per infusione» 1 flacone 2 g con dispositivo Monovial;
025212097 - «1 g/100 ml polvere e solvente per soluzione per infusione» 1 flacone polvere, con dispositivo "Monovial" + sacca infusionale da 100 ml;
025212109 - «2 g/100 ml polvere e solvente per soluzione per infusione» 1 flacone 2 g, con dispositivo "Monovial" + sacca infusionale da 100 ml;
025212111 - «1 g polvere per soluzione iniettabile» 10 flaconcini;
025212123 - «1 g polvere per soluzione iniettabile» 25 flaconcini. Procedure: UK/H/xxx/WS/076. Tipologia delle variazioni: C.I.4) Titolare AIC: Glaxosmithkline S.p.a. Stampati 1. Il Titolare dell'Autorizzazione all'immissione in commercio deve apportare le modifiche autorizzate, dalla data di entrata in vigore della presente Determinazione 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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