COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio del medicinale «Imovax Tetano» (11A13468)
Estratto determinazione V & A/N/V n. 1195 del 4 ottobre 2011
Medicinale: IMOVAX TETANO.
Titolare A.I.C.: Sanofi Pasteur MSD Snc con sede legale e domicilio in 8, Rue Jonas Salk - 69367 Lyon Cedex 07 (Francia).
Variazione A.I.C.: B.I.b.2.d Modifica nella procedura di prova del principio attivo o delle materie prime, reattivi o sostanze intermedie utilizzati nel procedimento di fabbricazione del principio attivo modifica (sostituzione) in un metodo di prova biologico, immunologico o immunochimico o in un metodo che utilizza un reattivo biologico per un principio attivo biologico, ad esempio impronta proteica, impronta glucidica, ecc.
L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata.
E' autorizzata la modifica relativa alla sostituzione dei test di identificazione di Clostridium...
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