COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Talate» (15A08999)
Estratto determina V&A n. 2035/2015 del 22 ottobre 2015 Autorizzazione della variazione relativamente al medicinale TALATE. E' autorizzata la seguente variazione: sostituzione del test dei pirogeni (RPT) con il test per le endotossine batteriche (LAL test) per il prodotto finito. relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Procedura: AT/H/0154/001-003/II/033 Tipologia della variazione: B.II.d.2.c) Titolare AIC: Baxalta Innovations Gmbh Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza...
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