COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Luxazone» (11A09653)
Estratto determinazione V & A/N/V n. 921 del 28 giugno 2011
Medicinale: LUXAZONE.
Titolare AIC: Allergan Pharmaceuticals Ireland con sede legale e domicilio in Castlebar Road - Westport County Mayo (Irlanda).
Variazione AIC: Richiesta rettifica determinazione.
Visti gli atti di Ufficio, alla Determinazione V & A.N/_n. 698 del 6 maggio 2011, concernente la «Modifica dei parametri di specifica e/o dei limiti del prodotto finito e la modifica al di fuori dei limiti di specifica approvati» del medicinale: «LUXAZONE» e' apportata la seguente modifica:
in luogo di:
E' autorizzata la modifica al di fuori della categoria di limiti di specifiche per il principio attivo, come di seguito riportato
leggasi:
E' autorizzata la modifica al di fuori della categoria di...
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