COMUNICATO - Autorizzazione all''immissione in commercio del medicinale «Daktarin Dermatologico». (12A10958)
Estratto determinazione V & A. n.1514 dell'8 ottobre 2012
Descrizione del medicinale e attribuzione n. A.I.C.:
e' autorizzata l'immissione in commercio del medicinale: «DAKTARIN DERMATOLOGICO» anche nella forma e confezione: «2% spray cutaneo, polvere» 1 contenitore con valvola spray 100 g con le specificazioni di seguito indicate, a condizione che siano efficaci alla data di entrata in vigore della presente determinazione:
Titolare A.I.C.: Janssen Cilag S.p.A. con sede legale e domicilio fiscale in 20093 - Cologno Monzese - Milano, Via Michelangelo Buonarroti, 23, Codice fiscale n. 00962280590.
Confezione: «2% spray cutaneo, polvere» 1 contenitore con valvola spray 100 g
A.I.C. n. 041411048 (in base 10) 17HSH8 (in base 32)
Forma Farmaceutica: Spray cutaneo, polvere
Validita' Prodotto Integro: 2 anni dalla data di fabbricazione
Produttori del principio attivo: Janssen Pharmaceutica N.V. Janssen Pharmaceuticalaan 3B-2440 Geel (Belgio) e Janssen Pharmaceutica Little Island, Industrial Estate 353 Country Cork - Irlanda
Produttore del prodotto finito: Janssen-Cilag S.p.A (stabilimento sito in Latina - Borgo S. Michele, Via C. Janssen (tutte)
Composizione: 100 g di polvere contengono:
Principio Attivo: Miconazolo nitrato 2 g
Eccipienti: Talco 76,25 g; Stearalconio ettorite 18,75 g...
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