Is Iron sucrose registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Iron sucrose, including ENCIFER 20MG/ML SOLU. FOR I.V. INJECTION (20 mg/ml, Solution for injection, SAR 13.70); FEROMAX 20MG/ML Injection* (20 mg/ml, Solution for injection, SAR 76.15); FEROSAC INJ 20MG-ML AMP (20 mg/ml, concentrate for solution for injection, SAR 94.00); FEROTON 20MG-ML SOLU. FOR I.V. INJECTION (20 mg/ml, Solution for injection, SAR 84.60); Feradef 100 mg injection (20 mg/ml, Solution for injection/concentrate for solution for infusion, SAR 68.55).

Is Iron sucrose approved by the US FDA?

Drugs@FDA lists 6 application product lines for Iron sucrose, including VENOFER (Prescription); IRON SUCROSE (Prescription); IRON SUCROSE (Prescription); IRON SUCROSE (Prescription); VENOFER (Discontinued).

Are there safety signals or safety updates for Iron sucrose?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2024-08-01).

Active substance

Iron sucrose

SFDA 6
US FDA 6
NHS prices 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ENCIFER 20MG/ML SOLU. FOR I.V. INJECTION	20 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 13.70	Generic · Prescription	Emcure Pharmaceuticals Ltd.	Valid
FEROMAX 20MG/ML Injection*	20 mg/ml	Solution for injection · Intravenous use	5 Vial	SAR 76.15	NCE · Prescription	Gulf Pharmaceutical Industries (Julphar)	Valid
FEROSAC INJ 20MG-ML AMP	20 mg/ml	concentrate for solution for injection · Intravenous use	5 Ampoule	SAR 94.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
FEROTON 20MG-ML SOLU. FOR I.V. INJECTION	20 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 84.60	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Feradef 100 mg injection	20 mg/ml	Solution for injection/concentrate for solution for infusion · Intravenous use	5 Ampoule	SAR 68.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Feromental 100 mg / 5 ml	20 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 68.55	Generic · Prescription	DAMMAM PHARMA	Valid

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML); ANEMIA IN CHRONIC KIDNEY DISEASE; CHRONIC KIDNEY DISEASE ASSOCIATED ANEMIA; MATERNAL AND CHILD HEALTHCARE- SUPPLEMENTATION FOR MOTHER AND CHILD

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

Product	Strength	Form · route	Applicant	Status	First approved
VENOFER	EQ 100MG IRON/5ML (EQ 20MG IRON/ML); EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML); EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	injectable · intravenous	AM REGENT	Prescription	6 Nov 2000
IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML); EQ 100MG IRON/5ML (EQ 20MG IRON/ML); EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	injectable · intravenous	INTL MEDICATION SYS	Prescription	8 Aug 2025
IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML); EQ 100MG IRON/5ML (EQ 20MG IRON/ML); EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	injectable · intravenous	SANDOZ	Prescription	8 Aug 2025
IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML); EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	injectable · intravenous	MYLAN LABS LTD	Prescription	8 Aug 2025
VENOFER	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML); EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	injectable · intravenous	AM REGENT	Discontinued	6 Nov 2000
IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	injectable · intravenous	MYLAN LABS LTD	Discontinued	8 Aug 2025

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Iron sucrose 100mg/5ml solution for injection vials	£51.20	5 vial	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 1 Aug 2024 VENOFER — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 31 Oct 2019 PRAC signal: Arteriospasm coronary
Action for MAH: update of the product information: Yes
EMA PRAC 16 May 2019 PRAC signal: Arteriospasm coronary
Action for MAH: update of the product information: No

All safety entries for iron sucrose →

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.