Amikacin (Amikacin Fresenius)
Amikacin
Fresenius Kabi Manufacturing SA (Pty) Ltd
Registration
- Applicant
- Fresenius Kabi Manufacturing SA (Pty) Ltd
- Registrations
- 4
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Amikacin 1 g/4 ML fresenius EACH 4 ml SOLUTION CONTAINS AMIKACIN SULPHATE EQUIVALENT TO 1 g AMIKACIN | 1 g/4 ml | 29068429/20.1.1/0684 | Registered | S4 | None |
| Amikacin 100 mg/2ml fresenius EACH 2 ml VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO 100 mg AMIKACIN | 100 mg/2ml | Y0175Y/20.1.1/175 | Registered | S4 | None |
| Amikacin 250 mg/2 ML fresenius EACH 2 ml VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO 250 mg AMIKACIN | 250 mg/2 ml | Y0176Y/20.1.1/176 | Registered | S4 | None |
| Amikacin 500 mg/2ml fresenius EACH 2 ml VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO 500 mg AMIKACIN | 500 mg/2ml | Y0178Y/20.1.1/178 | Registered | 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 Amikacin sulphate equivalent to amikacin
S4: Amikacin
Consolidated Schedules 06 July 2026, line 5216
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.
(2S)-4-Amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-[(2S,3R,4S,5S,6R)-4-amino-3,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4-[(2R,3R,4S,5S,6R)-6-(aminomethyl)-3,4,5-trihydroxyoxan-2-yl]oxy-3-hydroxycyclohexyl]-2-hydroxybutanamide
Drag to rotate. Structure from PubChem CID 37768.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.