COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale «Flucis».
Estratto provvedimento UPC/II/592 del 21 ottobre 2008
Specialita' medicinale: FLUCIS.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: CIS BlO S.p.a.
Numero procedura mutuo riconoscimento: FR/H/0207/001/II/014.
Tipo di modifica: aggiornamento metodica chimica/farmaceutica.
Modifica apportata: aggiornamento di alcune sezioni del modulo 3 (sezioni 3.2.S, 3.2.P.3.3 e 3.2.P.5.4) e del modulo 2 (2.3.S, 2.3.P.3 e 2.3.P.5).
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