Itraconazole
Sold as Sporanox, Adco-sporozole, Fungikem, Mynoscend, Itraconazole ascend, Mylan itraconazole, Trisporal, Itraconazole oethmaan
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.
Background
Registration
- Applicants
- 5
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Janssen Pharmaceutica (Pty) Ltd1 of 3 cancelled | Sporanox, Trisporal | 10 mg/ml, 100 mg | 300429, A390617, W0043 | S4 | PIPIL |
| Adcock ingram limited | Adco-sporozole | Not stated | 370559 | S4 | None |
| Ascend Laboratories (Pty) Ltd | Fungikem, Mynoscend, Itraconazole ascend | 100 | 530383, 530384.383, 530385.383 | S4 | None |
| Viatris Healthcare (Pty) Ltd | Mylan itraconazole | 100 mg | A390383 | S4 | None |
| Oethmaan Biosims (Pty) Ltd | Itraconazole oethmaan | 100 | A400071 | S4 | None |
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 |
| Adco-sporozole EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | Not listed | 37055937/20.2.2/0559 | Registered | S4 | None |
| Fungikem EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | Not listed | 53038353/20.2.2/0383 | Registered | S4 | None |
| Mynoscend EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | Not listed | 530384.38353/20.2.2/0384.383 | Registered | S4 | None |
| Itraconazole 100 ascend EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | 100 | 530385.38353/20.2.2/0385.383 | Registered | S4 | None |
| Mylan itraconazole 100 MG EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | 100 mg | A390383A39/20.1.7/0383 | Registered | S4 | None |
| Trisporal EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | 100 mgCapsules | A390617A39/20.2.2/0617Approved 18 October 2022 | Registered | S4 | PIPIL |
| Itraconazole 100 oethmaan EACH CAPSULE CONTAINS ITRACONAZOLE 100,0 mg | 100 | A400071A40/20.2.2/0071 | Registered | S4 | None |
| 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.
SAHPRA documents
Schedule Verification
Trisporal, Janssen Pharmaceutica (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.