Decitabine
Sold as Dacogen, Cocitred, Tocenar, Darbect, Decitabine accord, Deceq
4-Amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2-one
Drag to rotate. Structure from PubChem CID 451668.
Background
Registration
- Applicants
- 4
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Janssen Pharmaceutica (Pty) LtdCertificate held by Janssen Pharmaceutica (Pty.) Ltd. | Dacogen | 20 mL | 460608 | S4 | PIPIL |
| Aurogen South Africa (Pty) LtdCertificate held by Aurogen SA (Pty) Ltd1 of 3 cancelled | Cocitred, Tocenar, Darbect | 50 mg | 550171, 550172.171, 550173.171 | S4 | PIPIL |
| Accord Healthcare (Pty) Ltd | Decitabine accord | 50 mg | 550374 | S4 | None |
| Equity Pharmaceutical (Pty) LtdCertificate held by Equity Pharmaceuticals (Pty) Ltd | Deceq | 50 mg | 560675 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Dacogen EACH 20,0 ml VIAL CONTAINS DECITABINE 50,0 mg | 20 mLPowder for concentrate for solution for infusion. | 46060846/26/0608Approved 5 October 2021 | Registered | S4 | PIPIL |
| Cocitred EACH VIAL CONTAINS DECITABINE 50,0 mg | Not listed | 55017155/26/0171 | Cancelled | S4 | None |
| Tocenar EACH VIAL CONTAINS DECITABINE 50,0 mg | 50 mgPowder for concentrate for solution for infusion | 550172.17155/26/0172.171Approved 25 April 2023 | Registered | S4 | PIPIL |
| Darbect EACH VIAL CONTAINS DECITABINE 50,0 mg | 50 mgPowder for concentrate for solution for infusion | 550173.17155/26/0173.171Approved 25 April 2023 | Registered | S4 | PIPIL |
| Decitabine 50 MG accord EACH VIAL CONTAINS DECITABINE 50,0 mg | 50 mg | 55037455/26/0374 | Registered | S4 | None |
| Deceq EACH VIAL CONTAINS DECITABINE 50,0 mg | 50 mgPowder for concentrate for solution for infusion | 56067556/26/0675Approved 12 December 2023 | Registered | S4 | PIPIL |
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.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.