COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Metronidazolo Baxter S.p.A.». (13A05409)
Estratto determinazione V &
A/912 del 10 giugno 2013_ Titolare AIC: BAXTER S.P.A. (codice fiscale 00492340583) con sede legale e domicilio fiscale in PIAZZALE DELL' INDUSTRIA, 20, 00144 - ROMA (RM) Italia Medicinale: METRONIDAZOLO BAXTER S.P.A. Variazione AIC: Modifica stampati L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica degli stampati (Punto 4.5 del RCP e corrispondente Paragrafo del Foglio Illustrativo) relativamente alle confezioni sottoelencate: AIC N. 034252015 - "0,5 G/100 ML SOLUZIONE PER INFUSIONE ENDOVENOSA" 1 FLACONE 100 ML AIC N...
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