Regulatory PathRegulatory requirements compared

Active substances

Calcium chloride + Magnesium chloride + Potassium chloride + Sodium chloride

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
HAEMODIALYSIS ACETATE CONC. SOLU.35X F-6210.7,9,5.22,3.56 g/l,g/l,g/l,g/lSolution · Intravenous use1 BottleSAR 30.75Generic · PrescriptionPharmaceutical Solution Industries (PSI)Valid
PLEGISOL SOLN6.430 , 3.253 , 1.193 , 0.176 mg/mlSolution for injection/infusion · Parenteral use1 BagSAR 65.60NCE · PrescriptionHOSPIRA INCWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
PLEGISOL IN PLASTIC CONTAINER17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100MLsolution · perfusion, cardiacHOSPIRAPrescription26 Feb 1982
CARDIOPLEGIC IN PLASTIC CONTAINER17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100MLsolution · perfusion, cardiacBAXTER HLTHCAREPrescription21 Apr 2000
CARDIOPLEGIC IN PLASTIC CONTAINER17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100MLsolution · perfusion, cardiacFRESENIUS KABI USAPrescription18 Feb 2022

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.