GALDERMA ITALIA S.P.A. -
Estratto comunicazione notifica regolare UVA del 3/5/2013 n. AIFA/V &
A/P/46547 Specialita' Medicinale: ONILAQ "5% smalto medicato per unghie" Confezione: 1 flacone da 2,5 ml + 30 limette per unghie, + 30 tamponi detergenti, + 30 spatole - AIC 041906013/M Titolare AIC: Galderma Italia S.p.A. Codice Pratica N. C1B/2012/1250 - MRP N. FR/H/0463/001/IB/001 Tipo di modifica: modifica stampati Tipologia variazione oggetto della modifica: C.I.3, IB forseen Modifica apportata: Aggiornamento del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e dell'Etichettatura come raccomandato durante la procedura di mutuo riconoscimento n. FR/H/0463/001/MR. L'applicant propone anche alcune modifiche editoriali (implementazione della nuova versione del QRD template). E' autorizzata la modifica degli stampati richiesta (paragrafi 2, 3, 4.2, 4.3, 4.6, 5.3, 6.1, 6.3, 6.4, 6.5 e 8 del Riassunto delle Caratteristiche...
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