Regulatory PathRegulatory requirements compared

Active substance

Ferric citrate coordination complex

Open in the medicines table

EMA European Union — centrally authorised medicines

Xoanacyl Averoa · Authorised · authorised 11 Jun 2025 · ATC V03AE08

Therapeutic indication (EMA)

Xoanacyl is indicated for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).

Fexeric Akebia Europe Limited · Lapsed · authorised 23 Sep 2015 · ATC V03AE

Therapeutic indication (EMA)

Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
XOANACYL 1 G FILM-COATED TABLETSPL 59248/0002AVEROAPOM

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.