COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Tetraspan» (16A04792)
Estratto determina V&A n. 904/2016 del 23 maggio 2016 E' autorizzata la seguente variazione: C.I.4 Presentazione dei protocolli di due studi randomizzati di fase IV (RCT) relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento TETRASPAN. Procedura: SE/H/xxxx/WS/100 Titolare AIC: B. Braun Melsungen AS Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in etichetta ai sensi dell'art. 1 comma 5 della determina...
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