Sodium hyaluronate
Sold as Biolone, Biolon prime, Legend, Suplasyn, Cystistat, Hylo-max eye, Provisc
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 5
- Registrations
- 7
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) Ltd | Biolone, Biolon prime | Not stated | 300194, 340302 | Not determined | None |
| Boehringer Ingelheim Animal Health South Africa (Pty) Ltd | Legend | Not stated | 98/4 | Not determined | None |
| Pharmaco Distribution (Pty) Ltd | Suplasyn, Cystistat | Not stated | A390352, A400062 | Not determined | None |
| Litha pharmaCancelled | Hylo-max eye | drops solution | A400648 | Not determined | None |
| Alcon Laboratories (SA) (Pty) LtdCancelled | Provisc | Not stated | X0408 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Biolone EACH 1 ml SOLUTION CONTAINS SODIUM HYALURONATE 10 mg | Not listed | 30019430/3/0194 | Registered | Not determined | None |
| Biolon prime EACH 0,8 ml SOLUTION CONTAINS SODIUM HYALURONATE 9,6 mg | Not listed | 34030234/15.4/0302 | Registered | Not determined | None |
| Legend EACH 1,0 ml SOLUTION CONTAINS SODIUM HYALURONATE 10,0 mg | Not listed | 98/498/3.1/4 | Registered | Not determined | None |
| Suplasyn EACH PRE-FILLED SYRINGE CONTAINS SODIUM HYALURONATE 20,0 mg | Not listed | A390352A39/3.2/0352 | Registered | Not determined | None |
| Cystistat EACH 50,0 ml SOLUTION CONTAINS SODIUM HYALURONATE 40,0 mg | Not listed | A400062A40/18.10/0062 | Registered | Not determined | None |
| Hylo-max eye drops solution EACH 1,0 ml SOLUTION CONTAINS SODIUM HYALURONATE 1,0 mg | Drops solution | A400648A40/32.5/0648 | Cancelled | Not determined | None |
| Provisc* EACH 1 ml SOLUTION CONTAINS SODIUM HYALURONATE 10 mg | Not listed | X0408X/3/408 | Cancelled | 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.
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.