Desuden var de foreslåede ændringer til ordlyden i produktoplysningerne utilstrækkelige til fuldt ud at redegøre for de negative konsekvenser ved HepB - effekten, der skyldes variationer i fremstillingsprocessen.
Furthermore, the proposed amendments to the PI wording were insufficient to adequately address negative consequences on HepB efficacy resulting from variances in the manufacturing process.