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C25H29I2NO3645.30 g/mol

(2-Butyl-1-benzofuran-3-yl)-[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 2157.

Registration

Applicants
2
Registrations
3
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Sandoz South Africa (Pty) LtdHexarone100, 200320650, 320651S4None
Hexal Pharma (SA) (Pty) LtdCancelledHexarone150 mg/3 mlA390155S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Hexarone 100

EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 100,0 mg

10032065032/6.2/0650RegisteredS4None
Hexarone 200

EACH TABLET CONTAINS AMIODARONE HYDROCHLORIDE 200,0 mg

20032065132/6.2/0651RegisteredS4None
Hexarone 150 mg/3 ML

EACH 3,0 ml SOLUTION CONTAINS AMIODARONE HYDROCHLORIDE 150,0 mg

150 mg/3 mlA390155A39/6.2/0155CancelledS4None

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 Amiodarone hydrochloride

  • S4: Amiodarone

    Consolidated Schedules 06 July 2026, line 5230

Pharmacological class: Cardiac depressants. (class 6.2)

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.

Background

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SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Research articles

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