Regulatory PathRegulatory requirements compared

Active substance

Imlifidase

Open in the medicines table

EMA European Union — centrally authorised medicines

Idefirix Hansa Biopharma AB · Authorised · authorised 25 Aug 2020 · ATC L04AA

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
IDEFIRIX 11 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSIONPLGB 46323/0002HANSA BIOPHARMA ABPOM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.