Amikacin

Sold as Amikacin fresenius, Safeline-amikacin sulphate, Safeline amikacin sulphate, Aspen amikacin, Cipla amikacin, Medpro amikacin, Amikacin pharma-q, Amikacin emcure, Amoglacin

C₂₂H₄₃N₅O₁₃585.60 g/mol

(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.

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Registration

Applicants: 6
Registrations: 20
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Fresenius Kabi Manufacturing SA (Pty) Ltd	Amikacin fresenius	1 g/4 ml, 100 mg/2ml, 250 mg/2 ml, 500 mg/2ml	290684, Y0175, Y0176, Y0178	S4	None
Safeline Pharmaceuticals (Pty) LtdCancelled	Safeline-amikacin sulphate, Safeline amikacin sulphate	1 G, 250, 500	320515, 320516, 370648	S4	None
Pharmacare limited û woodmead	Aspen amikacin	100 mg/2 ml, 500 mg/2 ml	360241, 360242	S4	None
Cipla Medpro (Pty) LtdCancelled	Cipla amikacin, Medpro amikacin	100, 250, 500	450186, 450187, 450188, 450189, 450190, 450191	S4	None
Pharma-q Holdings (Pty) LtdCancelled	Amikacin pharma-q	500 mg/2 ml	511065	S4	PI PIL
Emcure- Pharmaceutical South Africa (Pty) Ltd	Amikacin emcure, Amoglacin	1,0 g/4 ml, 1 g/4 ml 500, 500 mg/2 ml	560263, 560265.263, 560266.264, 560364	S4	None

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
Safeline-amikacin sulphate 250 EACH 2,0 ml SOLUTION CONTAINS AMIKACIN SULPHATE 250,0 mg	250	32051532/20.1.1/0515	Cancelled	S4	None
Safeline - amikacin sulphate 500 EACH 2,0 ml SOLUTION CONTAINS AMIKACIN SULPHATE 500,0 mg	- 500	32051632/20.1.1/0516	Cancelled	S4	None
Aspen amikacin 100 mg/2 ML EACH 2,0 ml VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 100,0 mg	100 mg/2 ml	36024136/20.1.1/0241	Registered	S4	None
Aspen amikacin 500 mg/2 ML EACH 2,0 ml VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 500,0 mg	500 mg/2 ml	36024236/20.1.1/0242	Registered	S4	None
Safeline-amikacin sulphate 1 g EACH 4,0 ml SOLUTION CONTAINS AMIKACIN SULPHATE 1000,0 mg	1 G	37064837/20.1.1/0648	Cancelled	S4	None
Cipla amikacin 100 EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 100,0 mg	100	45018645/20.1.1/0186	Cancelled	S4	None
Cipla amikacin 250 EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 250,0 mg	250	45018745/20.1.1/0187	Cancelled	S4	None
Cipla amikacin 500 EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 500,0 mg	500	45018845/20.1.1/0188	Cancelled	S4	None
Medpro amikacin 100 EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 100,0 mg	100	45018945/20.1.1/0189	Cancelled	S4	None
Medpro amikacin 250 EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 250,0 mg	250	45019045/20.1.1/0190	Cancelled	S4	None
Medpro amikacin 500 EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 500,0 mg	500	45019145/20.1.1/0191	Cancelled	S4	None
Amikacin 500 mg/ 2ml pharma-q EACH 2,0 ml VIAL CONTAINS: AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 500,0 mg	500 mg/2 mlSolution for injection	51106551/20.1.1/1065Approved 23 March 2026	Cancelled	S4	PI PIL
Amikacin 500 mg/2 ML emcure EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 500,0 mg	500 mg/2 ml	56026356/20.1.1/0263	Registered	S4	None
Amoglacin 500 mg/2 ML EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 500,0 mg	500 mg/2 ml	560265.26356/20.1.1/0265.263	Registered	S4	None
Amoglacin 1,0 g/4 ML EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 1,0 g	1,0 g/4 ml	560266.26456/20.1.1/0266.264	Registered	S4	None
Amikacin 500 1 g/4 ML emcure EACH VIAL CONTAINS AMIKACIN SULPHATE EQUIVALENT TO AMIKACIN 1,0 g	1 g/4 ml 500	56036456/20.1.1/0264	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

S0S1S2S3S4S5S6S7S8

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Amikacin 500 mg/ 2ml pharma-q, Pharma-q Holdings (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsAmikacin 500 mg/ 2ml pharma-q, Pharma-q Holdings (Pty) Ltd Patient information leaflet (PIL)For patients and carersAmikacin 500 mg/ 2ml pharma-q, Pharma-q Holdings (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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