Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years).

No clinical added value of the new forms compared to the forms already available.


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of SIMULECT (basiliximab) is substantial in the MA indication.


Clinical Added Value

no clinical added value

These medicinal products are range supplements that do not provide any clinical added value (CAV V) compared to the forms already listed.