COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale «Beriplast P». (12A08961)
Estratto determinazione V & A 941 del 2 luglio 2012_
Specialita' medicinale: BERIPLAST P.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare AIC: CSL BEHRING GMBH.
Numero procedura mutuo riconoscimento: DE/H/0135/001-003/II/043.
Tipo di modifica: aggiornamento metodica chimica/farmaceutica.
Modifica apportata: revisione della procedura P-197 e della procedura per il controllo della qualita' Q-197 (Aprotinina soluzione per Beriplast P). Eliminazione di controlli in process.
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