COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Triaxis». (16A08437)
Estratto determina AMM/VMB n. 1914 del 16 novembre 2016 E' autorizzata la seguente variazione: B.I.a.1 e) modifica della fonte e del fornitore della L-Cisteina cloroidrato monoidrato utilizzata nel processo di produzione della componente acellulare della pertosse relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: DE/H/1933/001-002/II/040/G Titolare AIC: Sanofi Pasteur MSD S.P.A. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in...
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