Gentamicin
Sold as Aspen gentamicin, Mylan gentamicin, Pharma-q gentamicin, Pharma-q gentamicin ( c/v), Garacoll implant, Genta phenix, Palacos r+g, Septopal beads & chains, Gentamycin ( ) fresenius, Gentamycin-fresenius ( ), Gentamix, Intramed fermentmycin, Beecham gentamicin, Gentamicin unimed
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 12
- Registrations
- 22
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acino Pharma (Pty) Ltd | Aspen gentamicin | 80 mg/2 ml | 300106 | Not determined | None |
| Viatris Healthcare (Pty) LtdCancelled | Mylan gentamicin | 80 mg | 300171 | Not determined | None |
| Pharma-q Holdings (Pty) Ltd | Pharma-q gentamicin, Pharma-q gentamicin ( c/v) | 20 mg/2 ml, 40 mg/1 ml, 40 mg/ml 2 ml, 80 mg/2 ml | 310441, 310442, 310443, 340131 | Not determined | None |
| Adcock Ingram Critical Care (Pty) Ltd | Pharma-q gentamicin ( c/v) | 10 mg/ml 2ml | 340130 | Not determined | None |
| Mc Pharma (Pty) Ltd1 of 3 cancelled | Garacoll implant, Septopal beads & chains | 32,5 mg, 130 mg | 340375, 340376, K0157 | Not determined | None |
| Phenix SA (Pty) Ltd | Genta phenix | 50 | 83/247 | Not determined | None |
| Trinity Pharma (Pty) Ltd | Palacos r+g | Not stated | H0046 | Not determined | None |
| Fresenius Kabi Manufacturing SA (Pty) Ltd2 of 5 cancelled | Gentamycin ( ) fresenius, Gentamycin-fresenius ( ) | 20 mg/2 ml, 40 mg/1 ml, 80 mg/2 ml | L0162, L0163, L0164, L0165, N0071 | Not determined | None |
| Adcock ingram limitedCancelled | Gentamix | injection | S0108 | Not determined | None |
| Bodene (Pty) Ltd Trading As Intramed | Intramed fermentmycin | infusion | U0155 | Not determined | None |
| Pharmaco Distribution (Pty) LtdCancelled | Beecham gentamicin | 80 mg/2 ml | W0076, X0125 | S4 | None |
| Unimed Healthcare (Pty) Ltd | Gentamicin unimed | 80 mg/2 ml | W0147 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aspen gentamicin injection 80 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 80,0 mg | 80 mg/2 mlInjection | 30010630/20.1.1/0106 | Registered | Not determined | None |
| Mylan gentamicin 80 MG EACH 2,0 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 80,0 mg | 80 mg | 30017130/20.1.1/0171 | Cancelled | Not determined | None |
| Pharma-q gentamicin injection 20 mg/2 ML EACH 2,0 ml AMPOULE CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 20,0 mg | 20 mg/2 mlInjection | 31044131/20.1.1/0441 | Registered | Not determined | None |
| Pharma-q gentamicin injection 40 mg/1 ML EACH 1,0 ml AMPOULE CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 40,0 mg | 40 mg/1 mlInjection | 31044231/20.1.1/0442 | Registered | Not determined | None |
| Pharma-q gentamicin injection 80 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 80,0 mg | 80 mg/2 mlInjection | 31044331/20.1.1/0443 | Registered | Not determined | None |
| Pharma-q gentamicin injection 10 mg/ml (2ml c/v) EACH 1,0 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 10,0 mg | 10 mg/ml 2mlInjection | 34013034/20.1.1/0130 | Registered | Not determined | None |
| Pharma-q gentamicin injection 40 mg/ml (2 ML c/v) EACH 1,0 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 40,0 mg | 40 mg/ml 2 mlInjection | 34013134/20.1.1/0131 | Registered | Not determined | None |
| Garacoll 32,5 MG implant EACH IMPLANT CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 32,5 mg | 32,5 mg | 34037534/14.2/0375 | Registered | Not determined | None |
| Garacoll 130 MG implant EACH IMPLANT CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 130,0 mg | 130 mg | 34037634/14.2/0376 | Registered | Not determined | None |
| Genta 50 phenix EACH 1 ml SOLUTION CONTAINS GENTAMICIN SULPHATE A EQUIVALENT TO GENTAMICIN 20 mg | 50 | 83/247 | Old Medicine | Not determined | None |
| Palacos r+g EACH 40,8 g PACKET CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO GENTAMICIN 0,50 g | Not listed | H0046H/20.1.1/46 | Registered | Not determined | None |
| Septopal beads & chains EACH BEAD CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 4,5 mg GENTAMICIN | Not listed | K0157K/20.1.1/157 | Cancelled | Not determined | None |
| 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 |
| Gentamix injection EACH 10 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 80 mg GENTAMICIN | Injection | S0108S/20.1.1/108 | Cancelled | Not determined | None |
| Intramed fermentmycin infusion EACH 100 ml CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 80 mg GENTAMICIN BASE | Infusion | U0155U/20.1.1/155 | Registered | Not determined | None |
| Beecham gentamicin ampoules 80 mg/2 ML EACH 2 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 80 mg GENTAMICIN | 80 mg/2 mlAmpoules | W0076W/20.1.1/76 | Cancelled | Not determined | None |
| Gentamicin 80 mg/2 ML unimed EACH 2 ml SOLUTION CONTAINS GENTAMICIN SULPHATE EQUIVALENT TO 80 mg GENTAMICIN | 80 mg/2 ml | W0147W/20.1.1/147 | Registered | Not determined | None |
| Beecham gentamicin vials 80 mg/2 ML EACH 2 ml SOLUTION CONTAINS GENTAMICIN SULPHATE 80 mg | 80 mg/2 mlVials | X0125X/20.1.1/125 | Cancelled | S4 | None |
Regulatory status
Where S4 sits on the scale
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 Gentamicin sulphate
S4: Gentamicin
Consolidated Schedules 06 July 2026, line 6521
Pharmacological class: Broad and medium spectrum antibiotics. (class 20.1.1)
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.