Ketoconazole (Kez)
Ketoconazole
Pharma Dynamics (Pty) Ltd
Registration
- Applicant
- Pharma Dynamics (Pty) Ltd
- Certificate holder
- Pharma Dynamics (Pty) Ltd
- Registrations
- 1
- Schedule source
- SAHPRA documentation
Variants
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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 Ketoconazole
S4: Ketoconazole
- preparations and mixtures containing not more than 1,0 per cent of ketoconazole when intended for the prevention and treatment of dandruff; (S0) or
- when intended for application to the skin. (S0, S1)
Consolidated Schedules 06 July 2026, lines 6841 to 6846
S1: Ketoconazole
- application to the skin,
- except preparations and mixtures containing not more than 1,0 percent of ketoconazole, when intended for the prevention and treatment of dandruff. (S0, S4)
Consolidated Schedules 06 July 2026, lines 589 to 594
Pharmacological class: Fungicides. (class 20.2.2)
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.
1-[4-[4-[[(2S,4R)-2-(2,4-Dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]ethanone
Drag to rotate. Structure from PubChem CID 47576.
SAHPRA documents
Schedule Verification
This medication's schedule (S3) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.