Miconazole (Gyno-brentan Vc, Tibozole, Dak-o-, Gyno-daktarin Vc, Daktarin, Gyno-daktarin)
Miconazole
Janssen Pharmaceutica (Pty) Ltd
Every registration of this product has been cancelled.
Registration
- Applicant
- Janssen Pharmaceutica (Pty) Ltd
- Registrations
- 6
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gyno-brentan vc 1 G MICONAZOLE NITRATE 20 MG | Not listed | 29060129/18.6/0601 | Cancelled | Not determined | None |
| Tibozole EACH TABLET CONTAINS MICONAZOLE NITRATE 10,0 mg | Not listed | 37010037/20.2.2/0100 | Cancelled | Not determined | None |
| Dak-o-gel EACH 1,0 g GEL CONTAINS MICONAZOLE 20,0 mg | Dak-o-gel | 44093244/20.2.2/0932 | Cancelled | Not determined | None |
| Gyno-daktarin vc* EACH 100 g CREAM CONTAINS MICONAZOLE 2 g | Not listed | G0061G/18.6/61 | Cancelled | Not determined | None |
| Daktarin cream* EACH 1 g CREAM CONTAINS MICONAZOLE NITRATE 20 mg | Cream | G0106G/13.9.2/106 | Cancelled | Not determined | None |
| Gyno-daktarin 200 MG EACH VAGINAL CAPSULE CONTAINS MICONAZOLE NITRATE 200 mg | 200 mg | L0368L/18.6/368 | Cancelled | 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: Miconazole
- except when intended for application to the skin; (S1) and
- except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis; (S1) and
- except when intended for human use in preparations containing 2 per cent or less of miconazole, when intended for the topical treatment of fungal infections of the mouth (oral candidiasis). (S2)
Consolidated Schedules 06 July 2026, lines 7125 to 7130
S2: Miconazole
- when intended for human use in preparations containing 2 percent or less of miconazole, for the topical treatment of fungal infections of the mouth (oral candidiasis). (S1, S4)
Consolidated Schedules 06 July 2026, lines 2347 to 2348
S1: Miconazole
- when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and
- when intended for application to the skin. (S4)
- except for topical treatment of fungal infections of the mouth. (S2)
Consolidated Schedules 06 July 2026, lines 838 to 851
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-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole
Drag to rotate. Structure from PubChem CID 4189.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.