COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Fibro-Vein». (15A06955)
Estratto determina V&A n. 1596 del 1° settembre 2015 Autorizzazione delle variazioni: 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, C.I.11.b) Modifiche concernenti la sicurezza, l'efficacia e la farmacovigilanza medicinali per uso umano e veterinario. Introduzione di obblighi e condizioni relativi ad un'autorizzazione all'immissione in commercio, o modifiche ad essi apportate, relativamente al medicinale FIBRO-VEIN. E' autorizzato l'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo e delle etichette, ed e' approvato il Risk Management Plan, versione 4, relativamente al medicinale «Fibro-Vein», nelle forme e confezioni sottoelencate: AIC n. 033012016 - «0,2%» 10 flaconcini multidose soluz uso ev 5 ml AIC n. 033012028 - «0,5%» 5 fiale monodose soluz uso ev 2 ml AIC n. 033012030 - «1%» 5 fiale monodose soluz uso ev 2 ml AIC n. 033012042 - «3%» 10 flaconcini multidose soluz uso ev 5 ml E' inoltre autorizzata la rettifica dello Standard Terms della descrizione delle confezioni da: AIC n. 033012016 - «0,2%» 10 flaconcini multidose soluz uso ev 5 ml AIC n. 033012028 - «0,5%» 5 fiale monodose soluz uso ev 2 ml AIC n. 033012030 - «1%» 5 fiale monodose soluz uso ev 2 ml AIC n. 033012042 - «3%» 10 flaconcini multidose soluz uso ev 5 ml a: AIC n. 033012016 - «0,2% soluzione iniettabile per uso endovenoso» 10 flaconcini vetro tipo I monodose 5 ml AIC n. 033012028 - «0,5% soluzione iniettabile per uso endovenoso» 5 fiale vetro tipo I monodose 2 ml AIC n. 033012030 - «1% soluzione iniettabile per uso endovenoso» 5 fiale vetro tipo I 2 ml AIC n. 033012042 - «3% soluzione iniettabile per uso endovenoso» 10 flaconcini vetro tipo I 5 ml Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: Mac Pharma S.r.l. (codice fiscale 03394170264) con sede legale e domicilio fiscale in via Terraglio...
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