COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Ringer Lattato Baxter» (14A06339)
Estratto determinazione V &
A n. 1597/2014 del 28 luglio 2014 Autorizzazione della variazione C.I.4) Modifiche concernenti la sicurezza, l'efficacia e la farmacovigilanza medicinali per uso umano e veterinario - Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati in materia di qualita', preclinici, clinici o di farmacovigilanza relativamente al medicinale RINGER LATTATO BAXTER E' autorizzato l'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo per i paragrafi dal 4.3, 4.4, 4.5 e 4.8, relativamente al medicinale RINGER LATTATO BAXTER, nelle forme e confezioni AIC N. 030939211 - "soluzione per infusione" 1 flaconcino 50 ml, AIC N. 030939223 - "soluzione per infusione" 1 flaconcino 100 ml, AIC N. 030939235 - "soluzione per infusione" 1 flaconcino 250 ml, AIC N. 030939247 - "soluzione per infusione" 1 flaconcino 500 ml, AIC N. 030939250 - "soluzione per infusione" 1 sacca clear-flex 100 ml, AIC N. 030939262 - "soluzione per infusione" 1 sacca clear-flex 250 ml, AIC N. 030939274 - "soluzione per infusione" 1 sacca clear-flex 500 ml, AIC N. 030939286 - "soluzione per infusione" 1 sacca clear-flex 1000 ml, AIC N. 030939298 - "soluzione per infusione" 20 flaconcini 500 ml, AIC N. 030939300 - "soluzione per infusione" 20 sacche clear-flex 500 ml, AIC N. 030939312 - "soluzione per infusione" 12 sacche clear-flex 1000 ml, AIC N. 030939324 - "soluzione per infusione" 20 sacche viaflo 500 ml, AIC N. 030939336 - "soluzione per infusione" 24 sacche viaflo 500 ml, AIC N. 030939348 - "soluzione per infusione" 10 sacche viaflo 1000 ml, AIC N. 030939351 - "soluzione per infusione" 12 sacche viaflo 1000 ml Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: Baxter S.P.A. con sede legale e domicilio fiscale in Piazzale dell'Industria, 20, 00144 - Roma (RM) Italia, (codice fiscale 00492340583) Stampati 1. Il Titolare...
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