COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio del medicinale 'Dexoket'
Estratto provvedimento UPC/II/ 3225 del 12 settembre 2007
Specialita' medicinale: DEXOKET.
Confezioni: autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Laboratori Guidotti S.p.A.
Numero Procedura mutuo riconoscimento: ES/H/0101/001-003/II/028.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata: aggiornamento delle sezioni 3.2.S.2.2, 3.2.S.2.3, 3.2.S.2.4, 3.2.S.2.6 in formato CTD del ASMF effettuato da Laboratori Guidotti, via Livornese, 897 - 56010 Pisa.
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