Regulatory PathRegulatory requirements compared

Active substances

Magnesium chloride + Sodium bicarbonate + Sodium chloride

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
NORMOCARB HF 250.21GM/100ML;2.8GM/100ML;9.07GM/100MLsolution · injectionDIALYSIS SUPSPrescription26 Jul 2006
NORMOCARB HF 350.21GM/100ML;3.97GM/100ML;8.3GM/100MLsolution · injectionDIALYSIS SUPSPrescription26 Jul 2006

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PRISM0CAL B22K0/0024416917.14 G / L; 2.12 G / L; 3.05 G / LSOLUTION · INTRAVENOUS; HAEMODIALYSISVANTIVE ULC

Components

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.