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C8H12N4O4228.21 g/mol

4-Amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2-one

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 451668.

Registration

Applicants
1
Registrations
1
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Janssen Pharmaceutica (Pty) LtdCertificate held by Janssen Pharmaceutica (Pty.) Ltd.Dacogen20 mL460608S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Dacogen

EACH 20,0 ml VIAL CONTAINS DECITABINE 50,0 mg

20 mLPowder for concentrate for solution for infusion.46060846/26/0608Approved 5 October 2021RegisteredS4None

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 Decitabine

  • S4: Decitabine

    Consolidated Schedules 06 July 2026, line 5962

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.

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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