COMUNICATO - Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale 'Duodopa'.
Estratto provvedimento UPC/II/3155/ del 20 giugno 2007
Specialita' medicinale: DUODOPA.
Confezioni: autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Solvay Pharmaceuticals GmbH.
Numero procedura mutuo riconoscimento: SE/H/0415/001/II/005.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata: Modifica delle specifiche del prodotto finito: aggiunta di un nuovo test (idrazina) alle specifiche del rilascio e alle specifiche della shelf-life.
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