COMUNICATO - Variazione di tipo II all''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale «Pantoprazolo Winthrop». (11A06463)
Estratto determinazione V & A.PC/II/302 del 21 aprile 2011
Specialita' medicinale: PANTOPRAZOLO WINTHROP.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Winthrop Pharmaceuticals Italia S.r.l.
Numero procedura mutuo riconoscimento: DE/H/0952/001/11/024.
Tipo di modifica: modifica dei parametri di specifica e/o dei limiti del prodotto finito. Modifica al di fuori dei limiti di specifica approvati.
Modifica apportata: modifica del limite del parametro «resistenza alla rottura» da...
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