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Nystatin (Candacide)

Nystatin

Ranbaxy Pharmaceutical (Pty) Ltd

S2Read from the PI-PIL document and verified

Registration

Applicant
Ranbaxy Pharmaceutical (Pty) Ltd
Certificate holder
Ranbaxy Pharmaceutical (Pty) Ltd
Registrations
1
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Candacide oral suspension

EACH 1,0 ml SUSPENSION CONTAINS NYSTATIN 100 000 u

100 000 iu per mlSuspension31028831/20.1.7/0288Approved 24 January 2022RegisteredS2PIPIL

Regulatory status

Where S2 sits on the scale

A pharmacist can sell it directly, without a prescription.

Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, 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 S2, read from the product's PI-PIL leaflet.

The Consolidated Schedules list this ingredient up to S4; the leaflet's S2 applies to this product.

Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Nystatin

  • S4: Nystatin

    • when intended for systemic use or the initial treatment of vaginal candidiasis;
    • except when presented as oral drops containing not more than 100 000 I.U. per millilitre, (S2)
    • 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)
    • except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

    Consolidated Schedules 06 July 2026, lines 7340 to 7356

  • S2: Nystatin

    • when presented as oral drops containing not more than100 000 I.U. per millilitre, and
    • 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 systemic use or the initial treatment of vaginal candidiasis, (S4)
    • except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

    Consolidated Schedules 06 July 2026, lines 2438 to 2449

  • S1: Nystatin

    • when intended for application to the skin, and
    • when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, and
    • except when presented as oral drops containing not more than 100 000 I.U. per millilitre, (S2)
    • except when intended for systemic use or the initial treatment of vaginal candidiasis, (S4)
    • except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

    Consolidated Schedules 06 July 2026, lines 926 to 937

Pharmacological class: Antifungal antibiotics. (class 20.1.7)

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.

No structure available

This product's active ingredient could not be matched to a single known compound.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S2) 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.

Background

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Research articles

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