Iron

Sold as Venofer, Equifer, Ferinject, Monofer, Rautevene, Innofer, Tevifer, Children's tonic, Ferrimed

S3Read from the PI-PIL document and verified

No structure available

This product's active ingredient could not be matched to a single known compound.

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Registration

Applicants: 7
Registrations: 14
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Takeda (Pty) LtdCertificate held by Pharmacare limited	Venofer, Ferinject, Ferrimed	injection, 50 mg/ 500 mg, capsules, syrup	320166, 450948, H0840, H0842	S3	PI PIL
Equity Pharmaceutical (Pty) Ltd	Equifer	Not stated	450335	Not determined	None
Acino Pharma (Pty) Ltd	Monofer	000 mg 1, 100 mg, 500 mg	460166, 460167, 460168	Not determined	None
Gen-eye (Pty) LtdCertificate held by Gen-eye (Pty) Ltd1	Rautevene	5 ml	460849	Not determined	PI PIL
Innovata pharmaceuticals	Innofer	Not stated	500580	Not determined	None
Teva Pharmaceuticals (Pty) Ltd	Tevifer	1 000, 100, 500	570484, 570485, 570486	Not determined	None
African Medicines (Pty) Ltd Trading As Pakmed Self Medication	Children's tonic	Not stated	G2615	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Venofer injection EACH 5,0 ml AMPOULE CONTAINS IRON 100,0 mg	Injection	32016632/8.3/0166	Registered	Not determined	None
Equifer EACH 1,0 ml SOLUTION CONTAINS IRON 20,0 mg	Not listed	45033545/8.3/0335	Registered	Not determined	None
Ferinject EACH 1,0 ml CONTAINS IRON 50,0 mg	50 mg/ 500 mgSolution for injection/infusion.	45094845/8.3/0948Approved 28 March 2025	Registered	S3	PI PIL
Monofer 100 MG EACH VIAL/AMPOULE CONTAINS IRON (III) ISOMALTOSIDE EQUIVALENT TO IRON 100,0 mg	100 mg	46016646/8.3/0166	Registered	Not determined	None
Monofer 500 MG EACH VIAL/AMPOULE CONTAINS IRON (III) ISOMALTOSIDE EQUIVALENT TO IRON 500,0 mg	500 mg	46016746/8.3/0167	Registered	Not determined	None
Monofer 1 000 MG EACH VIAL/AMPOULE CONTAINS IRON (III) ISOMALTOSIDE EQUIVALENT TO IRON 1 000,0 mg	000 mg 1	46016846/8.3/0168	Registered	Not determined	None
Rautevene EACH AMPOULE CONTAINS IRON 100,0 mg	5 mlSolution for injection / concentrate for solution for infusion	46084946/8.3/0849Approved 9 February 2022	Registered	Not determined	PI PIL
Innofer EACH 5,0 ml SOLUTION CONTAINS IRON 100,0 mg	Not listed	50058050/8.3/0580	Registered	Not determined	None
Tevifer 100 EACH 2,0 ml SOLUTION CONTAINS FERRIC CARBOXYMALTOSE EQUIVALENT TO IRON 100,0 mg	100	57048457/8.3/0484	Registered	Not determined	None
Tevifer 500 EACH 10,0 ml SOLUTION CONTAINS FERRIC CARBOXYMALTOSE EQUIVALENT TO IRON 500,0 mg	500	57048557/8.3/0485	Registered	Not determined	None
Tevifer 1 000 EACH 20,0 ml SOLUTION CONTAINS FERRIC CARBOXYMALTOSE EQUIVALENT TO IRON 1 000,0 mg	1 000	57048657/8.3/0486	Registered	Not determined	None
Children's tonic EACH 5 ML MIXTURE CONTAINS IRON A 10,5 MG	Not listed	G2615	Old Medicine	Not determined	None
Ferrimed capsules EACH CAPSULE CONTAINS IRON A 50,0 mg	Capsules	H0840	Old Medicine	Not determined	None
Ferrimed syrup EACH 5 ML CONTAINS IRON POLYMALTOSE A EQUIVALENT TO 50,0 mg IRON	Syrup	H0842	Old Medicine	Not determined	None

Regulatory status

Where S3 sits on the scale

S0S1S2S3S4S5S6S7S8

Needs a doctor's prescription, dispensed by a pharmacist.

Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S3, read from the product's PI-PIL leaflet.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Iron

S3: Iron
- in preparations thereof for injection; (S0)
- except in oral preparations or mixtures containing more than 24 mg of elemental iron per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 3808 to 3820
S1: Iron
- in oral preparations or mixtures containing more than 24 mg of elemental iron per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0)
- except in preparations thereof for injection; (S3)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 571 to 579

Pharmacological class: Erythropoietics (haematinics). (class 8.3)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Ferinject, Takeda (Pty) Ltd is scheduled S3 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsFerinject, Takeda (Pty) Ltd Patient information leaflet (PIL)For patients and carersFerinject, Takeda (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

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