COMUNICATO - Autorizzazione della variazione relativamente al medicinale per uso umano «Tegretol». (14A08349)
Estratto determinazione V &
A_n. 2139_del 14 ottobre 2014 Autorizzazione della variazione: C.I.4) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, relativamente al medicinale TEGRETOL;
E' autorizzato l'aggiornamento del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo, relativamente al medicinale TEGRETOL, nelle forme e confezioni sottoelencate: AIC n. 029561038 - «10 mcg/ml polvere e solvente per soluzione iniettabile» 1 flacone polvere + 1 siringa preriempita da 1 ml AIC n. 029561040 - «20 mcg/ml polvere e solvente per soluzione iniettabile» 1 flacone polvere + 1 siringa preriempita da 1 ml AIC n. 029561053 - «10 mcg/ml polvere e solvente per soluzione iniettabile» 5 flac da 10 mcg + 5 fiale da 1ml AIC n. 029561065 - «20 mcg/ml polvere e solvente per soluzione iniettabile» 5 flac da 20 mcg + 5 fiale da 1ml AIC n. 029561103 - «5 mcg/ml polvere e solvente per soluzione iniettabile» 1 flacone + 1 siringa preriempita da 1 ml AIC n. 029561115 - «5 mcg/ml polvere e solvente per soluzione iniettabile» 5 flac da 5 mcg + 5 fiale da 1 ml Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: NOVARTIS Farma S.P.A. (codice fiscale 07195130153) con sede legale e domicilio fiscale in Largo Umbero Boccioni, 1, 21040 - Origgio - Varese (VA) Italia 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...
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