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Idefirix is a medicine used to prevent the body from rejecting a newly transplanted kidney.
Idefirix is used before transplantation in adults who have antibodies against the donor kidney and are considered ’highly sensitised’ based on a positive crossmatch test. It should be reserved for patients who are unlikely to obtain a transplant under the available kidney allocation system.
Graft organ rejection following solid organ transplantation is rare, and Idefirix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 January 2017.
Idefirix contains the active substance imlifidase.
Idefirix : EPAR - Medicine overview (PDF/121.66 KB)
First published: 28/08/2020
Idefirix : EPAR - Risk-management-plan summary (PDF/142.85 KB)
First published: 28/08/2020
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This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Hansa Biopharma AB
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P.O. Box 785
13/01/2023 Idefirix - EMEA/H/C/004849 - IAIN/0012
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.