GALDERMA ITALIA - S.p.a.
Modifiche secondarie di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Comunicazioni Agenzia italiana del farmaco del 30 agosto 2006). Codici pratiche n. a) N1B/06/464, b) N1B/06/465 e c) N1A/06/758.
Titolare: Galderma Italia S.p.a., sede legale, via dell'Annunciata n. 21, 20121 Milano, Uffici commerciali ed amministrativi centro direzionale Colleoni, 20041 Agrate Brianza (MI).
Specialita' medicinale: ROZEX.
Confezione e numero A.I.C.:
'0,75% emulsione cutanea' 1 tubo da 15 g - A.I.C. n. 028809046
'0,75% emulsione cutanea' 1 tubo da 50 g - A.I.C. n. 028809059
'0,75% emulsione cutanea' 1 flacone da 60 g - A.I.C. n. 028809061.
Modifiche apportate ai sensi del regolamento (CE) n. 1084/2003 (legge 24 dicembre 2003, n. 350):
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modifica secondaria tipo IB n. 42.a.1 Modifica della validita' del prodotto finito come confezionato per la vendita, prolungamento del periodo di validita' del prodotto finito da 24 mesi a 3 anni;
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modifica secondaria tipo IB n. 42.b Modifica delle condizioni di conservazione del prodotto finito o del prodotto diluito/ricostituito, modifica delle condizioni di conservazione del prodotto finito da: conservare a temperatura tra 2-8. C, Non congelare a: non conservare a temperatura superiore a 25. C;
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