Polifarma S.p.A.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinali per uso umano. Modifica apportata ai sensi del Decreto Legislativo 29 dicembre 2007, n.274
TITOLARE: POLIFARMA S.p.A. - Viale dell'Arte, 69 - 00144 Roma SPECIALITA' MEDICINALE: CEPIM CONFEZIONE E NUMERI AIC:
'500 mg/1,5 ml polvere e solvente per soluzione iniettabile' 1 flacone polvere +1 fiala solvente 1,5 ml AIC n. 028896013 (sospesa) '1 g/3 ml polvere e solvente per soluzione iniettabile' 1 flacone polvere +1 fiala solvente 3 ml AIC n. 028896025 '2 g/10 ml polvere e solvente per soluzione iniettabile' 1 flacone polvere+1 fiala solvente 10 ml AIC n. 028896037 (sospesa) MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: N. 33:
modifica minore del processo di produzione del prodotto finito:
PREPARAZIONE DELLA MISCELA CEFEPIME CLORIDRATO STERILE/L-ARGININA STERILE AGGIUNTA DI UNO STEP PER AGGIUSTAMENTO pH.
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: N.
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a): modifica minore di una procedura di prova approvata:
IDENTIFICAZIONE DEL PRINCIPIO ATTIVO CEFEPIME E DELL'ECCIPIENTE L-ARGININA.
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: N.
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b): aggiunta di un parametro di prova al termine del periodo di validita' del prodotto finito: IMPUREZZE E DEGRADANTI.
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: N.
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b) e conseguente 38.c): aggiunta di un nuovo parametro di prova al rilascio ed alla fine del periodo di validita' del prodotto finito CONTAMINAZIONE PARTICELLARE E CONSEGUENTE AGGIUNTA DELLA RELATIVA METODICA ANALITICA.
MODIFICA APPORTATA AI SENSI DEL REGOLAMENTO (CE) 1084/2003: N.
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a): restringimento dei limiti di una specifica al termine del...
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