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 12 Giugno 2008. Codice pratica N1B/08/881.
Specialita' medicinale: DOTAREM.
Confezione e numero A.I.C.: "0,0025 mmol/ml soluzione iniettabile per uso intraarticolare" 1 siringa preriempita 20 ml - AIC n° 029724097.
Modifica apportata ai sensi del Regolamento (CE) n. 1084/2003: n° 42.a.1: Estensione del periodo di validita' del prodotto finito come confezionato per la vendita, da 18 mesi a 3anni.
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