Idefirix
What Idefirix is used for
Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Idefirix
- Active substance
- imlifidase
- Disease area
- Desensitization, Immunologic; Kidney Transplantation
- Medicine group
- Immunosuppressants
- ATC code
- L04AA
- Marketing authorisation holder
- SERB SA
- Authorised in the EU since
- 2020
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Idefirix used for?
Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
What is the active substance in Idefirix?
Idefirix contains imlifidase.
Who makes Idefirix?
The EU marketing authorisation holder is SERB SA.
Is Idefirix an orphan medicine?
Yes. Idefirix is designated an orphan medicine in the EU, for a rare disease (Desensitization, Immunologic; Kidney Transplantation).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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