Fluconazole (Diflucan, Diflucan Iv)
Fluconazole
Pfizer Laboratories (Pty) Ltd
Registration
- Applicant
- Pfizer Laboratories (Pty) Ltd
- Registrations
- 9
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Diflucan capsules 100 MG EACH CAPSULE CONTAINS FLUCONAZOLE 100 mg | 100 mgCapsules | 28015028/20.2.2/0150 | Registered | Not determined | None |
| Diflucan capsules 200 MG EACH CAPSULE CONTAINS FLUCONAZOLE 200 mg | 200 mgCapsules | 28015128/20.2.2/0151 | Registered | Not determined | None |
| Diflucan 50 mg/ 5 ML EACH 5 ml SUSPENSION CONTAINS FLUCONAZOLE 50,0 mg | 50 mg/ 5 ml | 30015030/20.2.2/0150 | Registered | Not determined | None |
| Diflucan 200 mg/ 5 ML EACH 5 ml SUSPENSION CONTAINS FLUCONAZOLE 200,0 mg | 200 mg/ 5 ml | 30015130/20.2.2/0151 | Registered | Not determined | None |
| Diflucan tablets 200 MG EACH TABLET CONTAINS FLUCONAZOLE 200,0 mg | 200 mgTablets | 35018735/20.2.2/0187 | Cancelled | Not determined | None |
| Diflucan capsules 50 MG EACH CAPSULE CONTAINS FLUCONAZOLE 50 mg | 50 mgCapsules | V0339V/20.2.2/339 | Cancelled | Not determined | None |
| Diflucan capsules 150 MG EACH CAPSULE CONTAINS FLUCONAZOLE 150 mg | 150 mgCapsules | V0340V/20.2.2/340 | Registered | Not determined | None |
| Diflucan iv infusion 50 ML EACH 1 ml SOLUTION CONTAINS FLUCONAZOLE 2 mg | 50 mlInfusion | Z0271Z/20.2.2/271 | Registered | Not determined | None |
| Diflucan iv infusion 100 ml* EACH 1 ml SOLUTION CONTAINS FLUCONAZOLE 2 mg | 100 mLInfusion | Z0272Z/20.2.2/272Approved 1 March 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, read from the product's PI-PIL leaflet.
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 Fluconazole
S4: Fluconazole
- except as a single dose of 150 mg when indicated for the following fungal infections in adults
- Vaginal candidiasis, recurrent
- Candidial balanitis associated with vaginal candidiasis. (S2)
Consolidated Schedules 06 July 2026, lines 6351 to 6355
S2: Fluconazole
- as a single dose of 150 mg when indicated for the following fungal infections in adults:
- Vaginal candidiasis, recurrent
- Candidial balanitis associated with vaginal candidiasis.
Consolidated Schedules 06 July 2026, lines 1994 to 1998
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-(2,4-Difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol
Drag to rotate. Structure from PubChem CID 3365.
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.