Itraconazole (Sporanox, Trisporal)
Itraconazole
Janssen Pharmaceutica (Pty) Ltd
Registration
- Applicant
- Janssen Pharmaceutica (Pty) Ltd
- Registrations
- 3
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sporanox 10 mg/ml EACH 1 ml SOLUTION CONTAINS: ITRACONAZOLE 10,0 mg | 10 mg/ml | 30042930/20.2.2/0429 | Cancelled | S4 | None |
| Trisporal EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | 100 mgCapsules | A390617A39/20.2.2/0617Approved 18 October 2022 | Registered | S4 | PIPIL |
| Sporanox EACH CAPSULE CONTAINS ITRACONAZOLE 100 mg | 100 mgCapsules | W0043W/20.2.2/43Approved 18 October 2022 | Registered | S4 | PIPIL |
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 Itraconazole
S4: Itraconazole
Consolidated Schedules 06 July 2026, line 6829
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.
2-Butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
Drag to rotate. Structure from PubChem CID 55283.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) 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.