Reason for request
Extension of the indication
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Clinical Benefit
Substantial |
The actual benefit is substantial. |
Clinical Added Value
minor |
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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