COMUNICATO - Variazione di Tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Dialinax» (11A05325)
Estratto determinazione V & A.PC/II/197 del 28 marzo 2011
Specialita' medicinale: DIALINAX.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento.
Titolare AIC: Farmaceutici Caber S.P.A.
Numero Procedura Mutuo Riconoscimento: FR/H/0201/001-002/II/022.
Tipo di Modifica: Aggiornamento metodica chimica/farmaceutica.
Modifica Apportata: Modifica delle specifiche del prodotto finito al rilascio e alla fine del periodo di validita' (eliminazione della prova di durezza).
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