Nucleus ehf
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274 - Modifica apportata ai sensi del regolamento n. 1084/2003/CE).
Specialita' medicinale equivalente: OXALIPLATINO NUCLEUS.
Confezioni e numeri di A.I.C.:
A.I.C. n. 038247/M in tutte le confezioni autorizzate.
Modifica tipo IB n. 42a1 (DCP n. UK/H/1046/01/IB/01, approvazione a livello europeo in data 24 luglio 2008) consistente nell'estensione del periodo di validita' del prodotto da 30 mesi a 36 mesi.
I lotti gia' prodotti alla data della pubblicazione nella Gazzetta Ufficiale possono...
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