SIMULECT (basiliximab) - Acute organ rejection
Opinions on drugs -
Posted on
Jul 18 2024
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. |