Gentamicin (Gentamycin ( ) Fresenius, Gentamycin-fresenius ( ))
Gentamicin
Fresenius Kabi Manufacturing SA (Pty) Ltd
Registration
- Applicant
- Fresenius Kabi Manufacturing SA (Pty) Ltd
- Registrations
- 5
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gentamycin 20 mg/2 ML (ampoules) fresenius EACH 2 ml AMPOULE CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 20 mg GENTAMICIN | 20 mg/2 ml(Ampoules) | L0162L/20.1.1/162 | Registered | Not determined | None |
| Gentamycin 40 mg/1 ML (ampoules) fresenius EACH 1 ml AMPOULE CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 40 mg GENTAMICIN | 40 mg/1 ml(Ampoules) | L0163L/20.1.1/163 | Registered | Not determined | None |
| Gentamycin 80 mg/2 ML (ampoules) fresenius EACH 2,0 ml AMPOULE CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 80,0 mg GENTAMICIN | 80 mg/2 ml(Ampoules) | L0164L/20.1.1/164 | Registered | Not determined | None |
| Gentamycin-fresenius 80 mg/2 ML (vials) EACH 2 ml VIAL CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 80 mg GENTAMICIN | 80 mg/2 ml(Vials) | L0165L/20.1.1/165 | Cancelled | Not determined | None |
| Gentamycin-fresenius 20 mg/2 ML (vials) EACH 2,0 ml VIAL CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 20,0 mg GENTAMICIN | 20 mg/2 ml(Vials) | N0071N/20.1.1/71 | 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.
Listings for this ingredient that could not be applied to this product
S4: Betamethasone
Consolidated Schedules 06 July 2026, line 5481
S4: Clotrimazole
- except when intended for application to the skin (S1) and when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis. (S1)
Consolidated Schedules 06 July 2026, lines 5859 to 5860
S4: Gentamicin
Consolidated Schedules 06 July 2026, line 6521
S1: Clotrimazole
- when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and
- when intended for application to the skin. (S4)
Consolidated Schedules 06 July 2026, lines 330 to 335
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.