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Diclofenac (Austell-diclofenac Sodium, Canorof)

Diclofenac

Austell Pharmaceuticals (Pty) Ltd

S3Read from the PI-PIL document and verified

Registration

Applicant
Austell Pharmaceuticals (Pty) Ltd
Registrations
2
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Austell-diclofenac sodium 25 mg/ml

EACH 1,0 ml SOLUTION CONTAINS DICLOFENAC SODIUM 25,0 mg

25 mg/ml36040536/3.1/0405RegisteredNot determinedNone
Canorof

EACH 1,0 mg SOLUTION CONTAINS DICLOFENAC SODIUM 25,0 mg

25 mgInjection57052657/3.1/0526Approved 27 September 2022RegisteredS3PIPIL

Regulatory status

Where S3 sits on the scale

Needs a doctor's prescription, dispensed by a pharmacist.

Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, 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 Diclofenac sodium

  • S3: Diclofenac

    • except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
    • except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
    • except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
    • except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days. (S2)

    Consolidated Schedules 06 July 2026, lines 3415 to 3427

  • S2: Diclofenac

    • when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S3)
    • when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 days;
    • except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
    • except when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S1)
    • except when intended for veterinary use. (S3)

    Consolidated Schedules 06 July 2026, lines 1807 to 1821

  • S1: Diclofenac

    • when intended for application to the skin and containing more than 1 % m/m of diclofenac; (S3)
    • except when intended for application to the skin and containing 1 % m/m or less of diclofenac subject to a maximum pack size of 50 grams; (S0)
    • except when intended for the emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days; (S2)
    • except when intended for human use only in the treatment of fever or mild to moderate pain of inflammatory origin, or for the treatment of post-traumatic conditions, subject to a maximum daily dose of 75 mg for a maximum treatment period of 5 day; (S2)
    • except when intended for veterinary use. (S3)

    Consolidated Schedules 06 July 2026, lines 365 to 379

Pharmacological class: Antirheumatics (anti-inflammatory agents). (class 3.1)

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.

C14H11Cl2NO2296.10 g/mol

2-[2-(2,6-Dichloroanilino)phenyl]acetic acid

Drag to rotate. Structure from PubChem CID 3033.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S3) has been verified from official SAHPRA documents with 90% confidence.

Professional information (PI)For healthcare professionalsPatient information leaflet (PIL)For patients and carers

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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