JANSSEN-CILAG S.P.A. -
Modifica secondaria di un'autorizzazione all'immissione in commercio di medicinale per uso umano, apportata ai sensi del d.l. 29 dicembre 2007, n. 274 - Modifica apportata ai sensi del regolamento CE 1234/2008 Titolare AIC: Janssen-Cilag SpA Ai sensi della determinazione AIFA 18 dicembre 2009, si informa dell'avvenuta approvazione delle seguenti variazioni: Medicinale: DAKTARIN Confezioni e numeri di AIC: 2% gel orale - 1 tubo da 80 g - AIC 024957060 0,2% soluzione vaginale - 5 flaconi 150 ml - AIC 024957250 Medicinale: DAKTARIN DERMATOLOGICO Confezioni e numeri di AIC: 2% soluzione cutanea - 1 flacone da 30 ml - AIC 041411036 Codice pratica N1A/13/492 B.III.1.a.2 Presentazione di un certificato di conformita' alla Farmacopea Europea nuovo o aggiornato per la sostanza attiva. Certificato aggiornato presentato da un...
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