COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio dei medicinali per uso umano «Pentavac» e «Tetravac» (18A07211)
Estratto determina AAM/PPA n. 958/2018 del 22 ottobre 2018 Si autorizzano le seguenti variazioni tipo II, B.I.b.2d) e B.II.b.2c): modifica del test ELISA per la valutazione dell'immunogenicita' del componente acellulare della pertosse eseguito sul drug substance e sul prodotto finito, relativamente alle specialita' medicinali PENTAVAC e TETRAVAC, nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Numeri procedura: worksharing EMA/H/XXX/WS/0964 («Pentavac» numero virtuale SE/H/0153/001/WS/131;
Tetravac
numero virtuale SE/H/0154/001/WS/092). Titolare A.I.C.: Sanofi Pasteur Europe (codice SIS 4285). Smaltimento scorte Sia i lotti gia' prodotti alla data di pubblicazione...
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