Feraheme Covis Pharma Europe B.V. · Application withdrawn · ATC B03AC
Therapeutic indication (EMA)
Intravenous treatment of iron deficiency anaemia
Active substance
Ferumoxytol
- US FDA 3
- EMA 2
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FERAHEME | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | solution · intravenous | AZURITY | Prescription | 30 Jun 2009 |
| FERUMOXYTOL | EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | solution · intravenous | SANDOZ | Prescription | 15 Jan 2021 |
| FERABRIGHT | EQ 300MG IRON/10ML (EQ 30MG IRON/ML); EQ 510MG IRON/17ML (EQ 30MG IRON/ML) | solution · intravenous | AZURITY | Prescription | 16 Oct 2025 |
EMA European Union — centrally authorised medicines
Rienso Takeda Pharma A/S · Withdrawn · authorised 15 Jun 2012 · ATC B03
Therapeutic indication (EMA)
Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD). The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Safety signals and safety-related labeling changes
- US FDA 27 May 2026 FERAHEME — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Ferumoxytol: risk of serious hypersensitivity reactions—contraindicated if any drug allergy; administer via infusion
New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
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), 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.