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IDEFIRIX (Hansa Biopharma (Australia) Pty Ltd)
Product name
IDEFIRIX
Date registered
Evaluation commenced
Decision date
Approval time
189 (255 working days)
Active ingredients
imlifidase
Registration type
NCE/NBE
Indication
Idefirix has provisional approval for the desensitisation treatment of highly sensitised adult kidney transplant candidates prior to kidney transplantation from a donor against whom there is a positive cross-match (see Section 5.1 Pharmacodynamic properties, Clinical trials). The use of Idefirix should be reserved for patients who are otherwise unlikely to receive a kidney transplant.
The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.