COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Sinestic» (10A04325)
Estratto provvedimento UVA.PC/II/193 del 22 marzo 2010
Specialita' medicinale: SINESTIC.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Biofutura Pharma S.p.a.
N. procedura mutuo riconoscimento: SE/H/0229/001-002/II/042.
Tipo di modifica: aggiornamento metodica chimica/farmaceutica.
Modifica apportata: modifica delle specifiche, minori cambiamenti nella metodologia analitica e microbiologica in accordo alla Farmacopea europea.
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