Iodine, iohexol
Sold as Omnipaque i/ml ( )
Background
Registration
- Applicants
- 1
- Registrations
- 4
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ge Healthcare (Pty) Ltd | Omnipaque i/ml ( ) | 300 mg 50 ml, 300 mg 100 ml, 350 mg 50 ml, 350 mg 100 ml | R0132, R0134, X0080, X0081 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Omnipaque injection 300 MG i/ml (50 ml) EACH 1 ml SOLUTION CONTAINS IOHEXOL ANHYDROUS, EQUIVALENT TO 300 mg IODINE | 300 mg 50 mlInjection | R0132R/28/132 | Registered | Not determined | None |
| Omnipaque injection 350 MG i/ml (50 ml) EACH 1 ml SOLUTION CONTAINS IOHEXOL ANHYDROUS, EQUIVALENT TO 350 mg IODINE | 350 mg 50 mlInjection | R0134R/28/134 | Registered | Not determined | None |
| Omnipaque injection 300 MG i/ml (100 ml) EACH 1 ml SOLUTION CONTAINS IOHEXOL ANHYDROUS, EQUIVALENT TO 300 mg IODINE | 300 mg 100 mlInjection | X0080X/28/80 | Registered | Not determined | None |
| Omnipaque injection 350 MG i/ml (100 ml) EACH 1 ml SOLUTION CONTAINS: IOHEXOL ANHYDROUS, EQUIVALENT TO 350 mg IODINE | 350 mg 100 mlInjection | X0081X/28/81 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
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
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
SAHPRA has not published a professional information or patient information leaflet for this product.