COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Albumeon». (15A03747)
Estratto determina V&A/797 del 29 aprile 2015 Autorizzazione della variazione: C.I.11.z) relativamente al medicinale: ALBUMEON Numero procedura europea: DE/H/1943/001/II/003 Titolare A.I.C.: CSL Behring S.p.a. E' autorizzata la seguente variazione: da: 1.8.2 Risk Management System Risk Management Plan 2.0 a: 1.8.2 Risk Management System Risk Management Plan 3.0 relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Smaltimento scorte Sia i lotti gia' prodotti alla data di entrata in vigore della...
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