Fidia Farmaceutici - S.p.a.
Modifiche secondarie di un'A.I.C. di specialita' medicinale per uso
umano
Comunicazione A.I.F.A. del 7 settembre 2005 - Codice pratica: N1A/05/1210.
Titolare: Fidia Farmaceutici S.p.a., via Ponte della Fabbrica n. 3/A, 35031 Abano Terme (PD).
Specialita' medicinale: VISOFID.
Confezione e numero di A.I.C.:
'2 mg + 0,035 mg compresse rivestite' 21 compresse - A.I.C. n. 035368012.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 5. Modifica del nome del produttore del prodotto finito: da Douglas Pharmaceuticals Ltd., con stabilimento sito in Central Park Drive, Lincoln, Auckland 8 (New Zealand) a: Douglas Manufacturing Ltd., con stabilimento sito in Central Park Drive, Lincoln, Auckland 8 (New Zealand).
Comunicazione A.I.F.A. del 17 ottobre 2005 - Codice pratica: N1A/05/1211.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 38a. Modifica minore della procedura di prova approvata del prodotto finito: modifica relativa ai metodi di controllo delle sostanze correlate.
Comunicazione A.I.F.A. del 17 ottobre 2005 - Codice pratica: N1A/05/1213.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 37a. Inasprimento dei limiti delle specifiche del prodotto finito: modifica del limite relativo alla determinazione quantitativa dei principi attivi (dall'intervallo 92.5-107.4% a 92,5-105%, corrispondente a 32,4-36,8 g e 1,85-2,10 mg rispettivamente per l'etinilestradiolo ed il ciproterone acetato.
Comunicazione A.I.F.A. del 17 ottobre 2005 - Codice pratica: N1A/05/1214.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 15a. Presentazione di un certificato di idoneita' della Farmacopea Europea nuovo o aggiornato da parte di un produttore attualmente approvato...
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