Optiray

C₁₈H₂₄I₃N₃O₉807.10 g/mol

1-N,3-N-Bis(2,3-dihydroxypropyl)-5-[(2-hydroxyacetyl)-(2-hydroxyethyl)amino]-2,4,6-triiodobenzene-1,3-dicarboxamide

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 3741.

Registration

Applicants: 1
Registrations: 16
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Guerbet South Africa (Pty) Ltd6 of 16 cancelled	Optiray	30 ml 300 -, 50 ml 320 -, 50 ml 240 -, 75 ml 300 -, 75 ml 320 -, 75 ml 350 -, 100 ml 300 -, 100 ml 240 -, 100 ml 350 -, 125 ml 300-, 125 ml 350-, 300, 320, 350, 500 ml 300 -, 500 ml 320 -	300281, 300282, 340099, 340100, A390614, A400245, A400246, Z0412, Z0414, Z0416, Z0417, Z0418, Z0419, Z0420, Z0421, Z0422	S4	PI PIL

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Optiray 300-125 ML EACH 125 ml SOLUTION CONTAINS : IOVERSOL 79,5 g	125 ml 300-	30028130/28/0281	Registered	S4	PI PIL
Optiray 350-125 ML EACH 125 ml SOLUTION CONTAINS : IOVERSOL 92,63 g	125 ml 350-	30028230/28/0282	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	PI PIL
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	PI PIL
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	PI PIL
Optiray 320 - 75 ML EACH 1,0 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO ORGANICALLY BOUND IODINE 320,0 mg	75 ml 320 -	A400245A40/28/0245	Cancelled	Not determined	PI PIL
Optiray 350 - 75 ML EACH 1,0 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO ORGANICALLY BOUND IODINE 350,0 mg	75 ml 350 -	A400246A40/28/0246	Cancelled	Not determined	PI PIL
Optiray 320 - 50 ML EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 320 mg ORGANICALLY BOUND IODINE	50 ml 320 -	Z0412Z/28/412	Registered	Not determined	PI PIL
Optiray 300 - 30 ML EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 300 mg ORGANICALLY BOUND IODINE	30 ml 300 -	Z0414Z/28/414	Cancelled	Not determined	PI PIL
Optiray 240 - 50 ML EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 240 mg ORGANICALLY BOUND IODINE	50 ml 240 -	Z0416Z/28/416	Cancelled	Not determined	PI PIL
Optiray 300 - 100 ML EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 300 mg ORGANICALLY BOUND IODINE	100 ml 300 -	Z0417Z/28/417	Registered	Not determined	PI PIL
Optiray 300 EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 300 mg ORGANICALLY BOUND IODINE	300Solution for injection	Z0418Z/28/418Approved 20 January 2026	Registered	S4	PI PIL
Optiray 240 - 100 ML EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 240 mg ORGANICALLY BOUND IODINE	100 ml 240 -	Z0419Z/28/419	Cancelled	Not determined	PI PIL
Optiray 350 EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 350 mg ORGANICALLY BOUND IODINE	350Solution for injection	Z0420Z/28/420Approved 20 January 2026	Registered	S4	PI PIL
Optiray 320 EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 320 mg ORGANICALLY BOUND IODINE	320Solution for injection	Z0421Z/28/421Approved 20 January 2026	Registered	S4	PI PIL
Optiray 350 - 100 ML EACH 1 ml SOLUTION CONTAINS IOVERSOL EQUIVALENT TO 350 mg ORGANICALLY BOUND IODINE	100 ml 350 -	Z0422Z/28/422	Registered	Not determined	PI PIL

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, matched to the Consolidated Schedules by ingredient, confidence high.

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 Ioversol

S4: Ioversol
Consolidated Schedules 06 July 2026, line 6798

Pharmacological class: Contrast media (class 28)

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.

Background

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SAHPRA documents

Professional information (PI)For healthcare professionalsOptiray 300-125 ML, Guerbet South Africa (Pty) Ltd. SAHPRA's document for Optiray Patient information leaflet (PIL)For patients and carersOptiray 300-125 ML, Guerbet South Africa (Pty) Ltd. SAHPRA's document for Optiray

These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.

Research articles

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