ZAMBON ITALIA s.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano Comunicazione Agenzia Italiana
del Farmaco del 02/04/2008 Codice pratica: N1A/08/513
Titolare: ZAMBON ITALIA s.r.l. - Via Lillo del Duca 10 - Bresso (MI)
Specialita' medicinale: EDENIL
"0,1 g soluzione vaginale" 5 flac. soluzione 100 ml - AIC 027741014
"0,1 g soluzione vaginale" 3 flac. soluzione 100 ml - AIC 027741040
Modifica apportata ai sensi del regolamento (CE) 1084/2003: n. 37.a - inasprimento dei limiti delle specifiche del prodotto finito (rilascio e shelf-life: totale delle impurezze minore/uguale 0,5%)
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