Fidia Farmaceutici S.p.A.
MODIFICA SECONDARIA DI UN'AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO DI MEDICINALE PER USO UMANO Modifiche apportate ai sensi del D.Lvo 29/12/2007, n.274
TITOLARE: FIDIA Farmaceutici S.p.A. - Via Ponte della Fabbrica 3/A - 35031 Abano Terme (PD) Specialita' medicinale: CLODRON Confezioni e numeri A.I.C.:
'400 mg capsule rigide' 10 capsule A.I.C. 034721050 'con Lidocaina 100 mg+33 mg soluzione iniettabile' 6 fiale AIC 034721074 'con Lidocaina 100 mg+33 mg soluzione iniettabile' -12 fiale AIC 034721086 '300 mg/10 ml concentrato per soluzione per infusione' - 6 fiale AIC 034721035 '300 mg/10 ml concentrato per soluzione per infusione' - 12 fiale AIC 034721047
Codice pratica: N1B/09/1110
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Tipo IB n. 12b)1: Aggiunta del parametro di prova 'volume apparente' alle specifiche del principio attivo e conseguente tipo IB n. 13.b:
aggiunta della procedura di prova metodo per la determinazione del volume apparente.
Codice pratica: N1B/09/1111
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Tipo IB n. 12b)1: modifica di una specifica del principio attivo:
aggiunta del limite di specifica per la granulometria della polvere.
Codice pratica: N1B/09/1108
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Tipo IB n. 12b)1: aggiunta del parametro di prova 'test di identificazione del sodio' alle specifiche del principio attivo e conseguente tipo IB n. 13.b: aggiunta della procedura di prova metodo per l'identificazione del sodio.
Codice pratica: N1B/09/1109
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Tipo IB n. 13.b: sostituzione di una procedura di prova del principio attivo: metodo per la determinazione del tetraisopropil clodronato.
Codice pratica...
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