COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Betamesol» (10A01820)
Estratto determinazione AIC/N/V n. 278 del 27 gennaio 2010
Medicinale: BETAMESOL.
Titolare AIC: Proge Farm S.r.l. con sede legale e domicilio fiscale in Largo Donegani, 4/A - 28100 Novara (codice fiscale n. 01419800030).
Variazione A.I.C.: Presentazione di un certificato d'idoneita' della Farmacopea europea nuovo o aggiornato da parte di un produttore attualmente approvato Adeguamento Standard Terms.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata:
E' autorizzata la modifica relativa alla presentazione di un CEP aggiornato per il principio attivo Betametasone Dipropionato da parte di un nuovo produttore.
Il CEP che si autorizza e': R0-CEP 2003-232-rev 00, produttore Farmabios S.p.A. - via Don Motti, 45 - 27027 Gropello Cairoli (Italia).
Relativamente alla confezione sottoelencata: A.I.C. n. 034058014 - «0,05% crema» tubo 30 g.
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