Fluconazole (Bio-fluconazole, Bio-fluconazole Iv)
Fluconazole
Biotech Laboratories (Pty) Ltd
Registration
- Applicant
- Biotech Laboratories (Pty) Ltd
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bio-fluconazole 50 MG EACH TABLET CONTAINS :FLUCONAZOLE 50,0 mg | 50 mg | 42056642/20.2.2/0566 | Registered | Not determined | None |
| Bio-fluconazole iv EACH 100,0 ml SOLUTION CONTAINS FLUCONAZOLE 200,0 mg | Not listed | 42068342/20.2.2/0683 | Registered | Not determined | None |
| Bio-fluconazole 150 MG EACH TABLET CONTAINS :FLUCONAZOLE 150,0 mg | 150 mg | 42068442/20.2.2/0684 | Registered | Not determined | None |
| Bio-fluconazole 200 MG EACH TABLET CONTAINS :FLUCONAZOLE 200,0 mg | 200 mg | 42069042/20.2.2/0690 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
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
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
SAHPRA has not published a professional information or patient information leaflet for this product.