Reason for request

Extension of the indication


Clinical Benefit


The actual benefit is substantial.

Clinical Added Value


No comparison is available with the triple therapy recommended for the prophylaxis of liver transplant rejection, combining mycophenolate mofetil/low-dose tacrolimus/corticosteroids. However, in view of the lesser reduction in glomerular filtration rate demonstrated with CERTICAN/low-dose tacrolimus/corticosteroids compared to standard-dose tacrolimus/corticosteroids at 12 months and 24 months, CERTICAN in combination with low-dose tacrolimus and corticosteroids provides a minor (IAB IV) improvement in actual benefit in the prophylaxis of transplant rejection in liver allograft recipients, in comparison with standard-dose tacrolimus combined with corticosteroids.

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