GUERBET Rappresentante per l'Italia: Guerbet SpA
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. Comunicazione dell'Agenzia Italiana del Farmaco del 26 Novembre 2007. Codice pratica N1B/07/745.
Specialita' medicinale: HEXABRIX. Confezioni e numeri A.I.C.:
"320 mg/ml soluzione iniettabile" flacone da 20 ml - AIC n. 026307025
"320 mg/ml soluzione iniettabile" flacone da 50 ml - AIC n. 026307037
"320 mg/ml soluzione iniettabile" flacone da 100 ml - AIC n. 026307049
"320 mg/ml soluzione iniettabile" flacone da 200 ml - AIC n. 026307064
Modifica apportata ai sensi del Regolamento (CE) n. 1084/2003: n° 14a - Modifica del sito del produttore gia' approvato (sostituzione o aggiunta) se non disponibile un certificato d'idoneita' della Farmacopea europea: Sostituzione del produttore dell'acido ioxaglico Guerbet, Aulnay sous Bois, 93, Francia col produttore...
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