Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, della specialita' medicinale .
Estratto provvedimento UPC/II/2533 del 30 ottobre 2006
Specialita' medicinale: MYRONYL.
Confezioni: autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Merck S.p.a.
Numero procedura mutuo riconoscimento: FR/H/0182/001/w12.
Tipo di modifica: modifica/aggiunta indicazione terapeutica.
Modifica apportata: estensione delle indicazioni all'eta' pediatrica relativamente ai bambini dai dieci anni di eta'.
In conformita' all'allegato che costituisce parte integrante del presente provvedimento il titolare dell'autorizzazione all'immissione in commercio deve apportare le necessarie modifiche al riassunto delle caratteristiche del prodotto dalla data di entrata in vigore del...
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