Iodine

Sold as Zedchem pvp-i, Xenetix, Imeron, Optiray, Omnipaque i/ml (polypropylene bottle), Scanlux, Omnipaque i/ml ( )

S4Read from the PI-PIL document and verified

I₂253.81 g/mol

Molecular iodine

Drag to rotate. Structure from PubChem CID 807.

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Registration

Applicants: 5
Registrations: 18
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Enaleni Pharmaceuticals (Pty) LtdCancelled	Zedchem pvp-i	cream	270053	Not determined	None
Guerbet South Africa (Pty) Ltd1 of 5 cancelled	Xenetix, Optiray	75 ml 300 -, 250, 300, 500 ml 300 -, 500 ml 320 -	310552, 310553, 340099, 340100, A390614	Not determined	None
Axim Pharmaceuticals (Pty) LtdCertificate held by Axim pharmaceuticals	Imeron	200mg/250mg/300mg/350mg/400mg	320714, 320715, 320716, 320717, 320718	S4	PI PIL
Ge Healthcare (Pty) Ltd	Omnipaque i/ml (polypropylene bottle), Omnipaque i/ml ( )	300 mg 200 ml, 300 mg 500 ml, 300 mg 20 ml, 350 mg 200 ml, 350 mg 500 ml	350381, 350383, 350389, 350391, R0131	Not determined	None
Medicine Developers International (Pty) Ltd	Scanlux	300 mg/ml, 370 mg/ml	410429, 410430	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Zedchem pvp-i cream EACH 1 g CREAM CONTAINS POVIDONE-IODINE EQUIVALENT TO 5,0 mg IODINE	Cream	27005327/13.1/0053	Cancelled	Not determined	None
Xenetix 250 EACH 1,0 ml SOLUTION CONTAINS IOBITRIDOL EQUIVALENT TO 250,0 mg IODINE	250	31055231/28/0552	Registered	Not determined	None
Xenetix 300 EACH 1,0 ml SOLUTION CONTAINS IOBITRIDOL EQUIVALENT TO 300,0 mg IODINE	300	31055331/28/0553	Registered	Not determined	None
Imeron 200 EACH 1,0 ml SOLUTION CONTAINS IOMEPROL EQUIVALENT TO IODINE 200,0 mg	200mg/250mg/300mg/350mg/400mgSolution for injection	32071432/28/0714Approved 30 September 2024	Registered	S4	PI PIL
Imeron 250 EACH 1,0 ml SOLUTION CONTAINS IOMEPROL EQUIVALENT TO IODINE 250,0 mg	200mg/250mg/300mg/350mg/400mgSolution for injection	32071532/28/0715Approved 30 September 2024	Registered	S4	PI PIL
Imeron 300 EACH 1,0 ml SOLUTION CONTAINS IOMEPROL EQUIVALENT TO IODINE 300,0 mg	200mg/250mg/300mg/350mg/400mgSolution for injection	32071632/28/0716Approved 30 September 2024	Registered	S4	PI PIL
Imeron 350 EACH 1,0 ml SOLUTION CONTAINS IOMEPROL EQUIVALENT TO IODINE 350,0 mg	200mg/250mg/300mg/350mg/400mgSolution for injection	32071732/28/0717Approved 30 September 2024	Registered	S4	PI PIL
Imeron 400 EACH 1,0 ml SOLUTION CONTAINS: IOMEPROL EQUIVALENT TO IODINE 400,0 mg	200mg/250mg/300mg/350mg/400mgSolution for injection	32071832/28/0718Approved 30 September 2024	Registered	S4	PI PIL
Optiray 300 - 500 ML EACH 1,0 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO IODINE 300,0 mg	500 ml 300 -	34009934/28/0099	Registered	Not determined	None
Optiray 320 - 500 ML EACH 1,0 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO IODINE 320,0 mg	500 ml 320 -	34010034/28/0100	Registered	Not determined	None
Omnipaque 300 MG i/ml 200 ML (polypropylene bottle) EACH 1,0 ml SOLUTION CONTAINS IOHEXOL EQUIVALENT TO IODINE 300,0 mg	300 mg 200 ml	35038135/28/0381	Registered	Not determined	None
Omnipaque 350 MG i/ml 200 ML (polypropylene bottle) EACH 1,0 ml SOLUTION CONTAINS IOHEXOL EQUIVALENT TO IODINE 350,0 mg	350 mg 200 ml	35038335/28/0383	Registered	Not determined	None
Omnipaque 300 MG i/ml 500 ML (polypropylene bottle) EACH 1,0 ml SOLUTION CONTAINS IOHEXOL EQUIVALENT TO IODINE 300,0 g	300 mg 500 ml	35038935/28/0389	Registered	Not determined	None
Omnipaque 350 MG i/ml 500 ML (polypropylene bottle) EACH 1,0 ml SOLUTION CONTAINS IOHEXOL EQUIVALENT TO IODINE 350,0 mg	350 mg 500 ml	35039135/28/0391	Registered	Not determined	None
Scanlux 300 mg/ml EACH 1,0 ml SOLUTION CONTAINS IOPAMIDOL EQUIVALENT TO IODINE 300,0 mg	300 mg/ml	41042941/28/0429	Registered	Not determined	None
Scanlux 370 mg/ml EACH 1,0 ml SOLUTION CONTAINS IOPAMIDOL EQUIVALENT TO IODINE 370,0 mg	370 mg/ml	41043041/28/0430	Registered	Not determined	None
Optiray 300 - 75 ML EACH 1,0 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO IODINE 300,0 mg	75 ml 300 -	A390614A39/28/0614	Cancelled	Not determined	None
Omnipaque injection 300 MG i/ml (20 ml) EACH 1 ml CONTAINS IOHEXOL (ANHYDROUS) EQUIVALENT TO 300 mg IODINE	300 mg 20 mlInjection	R0131R/28/131	Registered	Not determined	None

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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 Iomeprol equivalent to iodine

S4: Iomeprol
Consolidated Schedules 06 July 2026, line 6786
S1: Iodine
- in oral preparations or mixtures containing more than 150 µg of Iodine per recommended daily dose alone or in combination with other active pharmaceutical ingredients. (S0)
Consolidated Schedules 06 July 2026, lines 566 to 569

Pharmacological class: Contrast media (class 28)

Matched through the component Iomeprol.

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

Imeron 200, Axim Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsImeron 200, Axim Pharmaceuticals (Pty) Ltd Patient information leaflet (PIL)For patients and carersImeron 200, Axim Pharmaceuticals (Pty) Ltd

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

Research articles

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