Modificazione dell'autorizzazione all'immissione in commercio della specialita' medicinale per uso umano
Estratto determinazione AIC/N/V n. 1036 del 29 settembre 2006
Medicinale: CUROXIM.
Titolare A.I.C.: Glaxosmithkline S.p.a. con sede legale e domicilio fiscale in via A. Fleming, 2 - 37100 Verona - codice fiscale n. 00212840235.
Variazione A.I.C.: Modifica delle procedure di prova del prodotto finito.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata:
E' autorizzato il sito GlaxoSmithKline Manufacturing S.p.a. di S. Polo di Torrile - Parma ad effettuare il rilascio parametrico per la sterilita' per lotti di fiale solvente di acqua per preparazioni iniettabili da 1 ml, 2 ml, 3 ml, 4 ml e 10 ml, relative al medicinale ´CUROXIM polvere e solventeª prodotto finito relativamente alle confezioni sottoelencate:
A.I.C. n. 023576010 - ´250 mg/ml polvere e solvente per sospensione iniettabile per uso intramuscolareª 1 flacone 250 mg + 1 fiala solvente 1 ml;
A.I.C. n. 023576022 - ´500 mg/2 ml polvere e solvente per sospensione iniettabile per uso intramuscolareª i flacone 500 mg + 1 fiala solvente 2 ml;
A.I.C. n. 023576034 - ´750 mg/3 ml polvere e solvente per sospensione iniettabileª 1 flacone polvere + 1 fiala solvente 3 ml;
A.I.C. n. 023576046 - ´1 g/4 ml polvere e solvente per sospensione iniettabile per uso intramuscolareª 1 flacone 1 g + 1 fiala solvente 4 ml;
A.I.C...
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