Regulatory PathRegulatory requirements compared

Active substance

Iron isomaltoside 1000

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MONOFER 100 mg/ml Solution For Injection/Infusion100 mg/mlSolution for injection/infusion · Intravenous use5 VialSAR 403.60NCE · PrescriptionPHARMACOSMOS A/SWithdrawn by MAH · Not Marketed
MONOFER 100 mg/ml Solution For Injection/Infusion100 mg/mlSolution for injection/infusion · Intravenous use5 VialSAR 2018.00NCE · PrescriptionPHARMACOSMOS A/SWithdrawn by MAH · Not Marketed

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.