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Cladribine (Litak)

Cladribine

Key Oncologics (Pty) Ltd

S4

Registration

Applicant
Key Oncologics (Pty) Ltd
Certificate holder
Key Oncologics (Pty) Ltd
Registrations
1
Schedule source
Consolidated Schedules 06 July 2026

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Litak 10

EACH 5,0 ml VIAL CONTAINS CLADRIBINE 10,0 mg

10 mg/ml.Solution for injection38005738/26/0057Approved 27 June 2025RegisteredS4PIPIL

Regulatory status

Where S4 sits on the scale

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, matched to the Consolidated Schedules by ingredient, confidence high.

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 Cladribine

  • S4: Cladribine

    Consolidated Schedules 06 July 2026, line 5823

Pharmacological class: Cytostatic agents (class 26)

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.

C10H12ClN5O3285.69 g/mol

(2R,3S,5R)-5-(6-Amino-2-chloropurin-9-yl)-2-(hydroxymethyl)oxolan-3-ol

Drag to rotate. Structure from PubChem CID 20279.

SAHPRA documents

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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