Omnipaque I/ml (Polypropylene Bottle)
Molecular iodine
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 807.
Registration
- Applicants
- 1
- Registrations
- 4
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ge Healthcare (Pty) Ltd | Omnipaque i/ml (polypropylene bottle) | 300 mg 200 ml, 300 mg 500 ml, 350 mg 200 ml, 350 mg 500 ml | 350381, 350383, 350389, 350391 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| 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 |
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.
Background
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.