COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Copaxone». (14A09458)
Estratto determina V &
A n. 2457/2014 del 20 novembre 2014 Procedura EU n.: UK/H/0453/002/II/141. E' autorizzata la seguente variazione: Introduzione di un Risk Management Plan (RMP) per la sostanza attiva glatiramer acetato. La versione del Risk Management Plan e' la 1.3. Relativamente al medicinale: COPAXONE. Ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Titolare A.I.C.: Teva Pharmaceuticals Limited. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino...
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