COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Pantoprazolo Nycomed». (11A09165)
Estratto determinazione V & A.PC/II/436 del 14 giugno 2011
Specialita' medicinale: PANTOPRAZOLO NYCOMED.
Confezioni:relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare AIC: Nycomed GmbH.
N. procedura mutuo riconoscimento: DE/H/1363/003/II/012/G.
Tipo di modifica:Sostituzione o aggiunta di un sito di fabbricazione per una parte o per la totalita' del procedimento di fabbricazione del prodotto finito.
Modifica della dimensione del lotto (comprese le categorie di dimensione del lotto) del prodotto finito. La modifica riguarda tutte le altre forme farmaceutiche fabbricate secondo procedimenti di fabbricazione complessi.
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