COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Gamten». (15A07811)
Estratto determina V&A n. 1892/2015 del 6 ottobre 2015 Medicinale: GAMTEN. Procedura EU n. DE/H/0479/001/II/029/G. Tipo II: B.II.d.2. c);
B.II.d.2. b). Si autorizzano le seguenti variazioni: modifica del metodo di determinazione della composizione proteica: da: elettroforesi su acetato di cellulosa (CAF), a: elettroforesi su gel d'agarosio (sistema semiautomatizzato: Hydrasys 2 scan);
modifica del metodo di determinazione degli HBs Ab e degli HAV-Ab: da: «Microparticle Enzyme Immuno Assay» (MEIA) utilizzando il sistema Abbott AxSYM, a: «Chemiluminescent immunoassay» utilizzando il sistema Beckman Access 2;
eliminazione della procedura di prova «Single Radial Immunodiffusion (SRID)» per la determinazione del contenuto di IgA nel prodotto finito;
determinazione del contenuto delle IgA, IgM e IgG nel prodotto finito con il sistema nefelometrico: Siemens BNII/BN P nephelometer ProSpec;
sostituzione della procedura di prova «Thrombin Generation Assay»...
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