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Simayla Fluconazole

Fluconazole

Every registration of this product has been cancelled.

Loading the molecular structure
C13H12F2N6O306.27 g/mol

2-(2,4-Difluorophenyl)-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 3365.

Registration

Applicants
1
Registrations
3

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Ranbaxy (SA) (Pty) LtdCancelledSimayla fluconazole50, 100, 200370118, 370119, 370121Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Simayla fluconazole 50

EACH CAPSULE CONTAINS FLUCONAZOLE 50,0 mg

5037011837/20.2.2/0118CancelledNot determinedNone
Simayla fluconazole 100

EACH CAPSULE CONTAINS FLUCONAZOLE 100,0 mg

10037011937/20.2.2/0119CancelledNot determinedNone
Simayla fluconazole 200

EACH CAPSULE CONTAINS FLUCONAZOLE 200,0 mg

20037012137/20.2.2/0121CancelledNot determinedNone

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.

Background

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SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Research articles

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