• CHMP identificerede, at den nedsatte immunogenicitet af den HepB- komponent, som er frigivet af indehaveren af markedsføringstilladelsen, skyldes variabiliteten i produktionsprocessen for denne komponent.
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.