COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Nebid» (16A06859)
Estratto determina V&A n. 1324/2016 del 9 agosto 2016 E' autorizzata la seguente variazione: modifica del processo di produzione del prodotto finito e di un metodo analitico. In particolare vengono modificate le condizioni relative alla sterilizzazione terminale. Modifica del metodo analitico finalizzato alla determinazione di assay ed impurezze del prodotto finito. Modifiche editoriali al modulo 3.2.P, relativamente alla specialita' medicinale NEBID ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: FI/H/0313/001/II/037/G. Titolare A.I.C.: Bayer S.p.a. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti...
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