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Azacitidine

Sold as Azacitidine DRL, Azacitidine eurolab, Intaza, Eurazic, Spalzact, Tazahaem, Diticaza, Azacitidine hetero, Azaturas, Azacitidine accord, Vidaza

S4Read from the PI-PIL document and verified
Loading the molecular structure
C8H12N4O5244.20 g/mol

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

Drag to rotate. Structure from PubChem CID 9444.

Background

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Registration

Applicants
7
Registrations
12
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd.Azacitidine DRL25 mg/ml510144S4PIPIL
Eurolab (Pty) LtdAzacitidine eurolab, EurazicNot stated510452, 511102S4None
Accord Healthcare (Pty) LtdIntaza, Azacitidine accord100 mg, 150 mg510453.452, 570489, 570490.0489S4PIPIL
Mc Pharma (Pty) LtdCertificate held by Ruby Pharmaceuticals (Pty) LtdSpalzact100 mg550559S4PIPIL
Hetero Drugs South Africa (Pty) LtdTazahaem, Diticaza, Azacitidine hetero100 mg560955, 560956.955, 560957.955S4PIPIL
Pharma-q Holdings (Pty) LtdAzaturas25 mg/ml561140S4None
Key Oncologics (Pty) LtdCertificate held by Key oncologicsVidaza100 mgA400521S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Azacitidine DRL

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

25 mg/mlLyophilised powder for injection51014451/26/0144Approved 28 March 2025RegisteredS4PIPIL
Azacitidine eurolab

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

Not listed51045251/26/0452RegisteredS4None
Intaza

EACH VIAL CONTAINS: AZACITIDINE 100, 0 mg

100 mgLyophilised powder for suspension for injection510453.45251/26/0453.452Approved 30 April 2026RegisteredS4PIPIL
Eurazic

EACH VIAL CONTAINS AZACITIDINE 100,0 mg

Not listed51110251/26/1102RegisteredS4None
Spalzact 100

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

100 mgPowder for suspension for injection55055955/26/0559Approved 13 December 2022RegisteredS4PIPIL
Tazahaem 100 mg/vial

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

100 mgInjection56095556/26/0955Approved 26 May 2026RegisteredS4PIPIL
Diticaza 100 mg/vial

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

100 mgInjection560956.95556/26/0956.955Approved 26 May 2026RegisteredS4PIPIL
Azacitidine 100 mg/vial hetero

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

100 mgInjection560957.95556/26/0957.955Approved 26 May 2026RegisteredS4PIPIL
Azaturas 25 mg/ml

EACH 1,0 ml SUSPENSION CONTAINS: AZACITIDINE 25,0 mg

25 mg/ml56114056/26/1140RegisteredS4None
Azacitidine 150 MG accord

Each vial contains: Azacitidine 150,0 mg

150 mgPowder for suspension for injection)57048957/26/489Approved 7 July 2025RegisteredS4PIPIL
Intaza 150

Each vial contains: Azacitidine 150,0 mg

100 mgLyophilised powder for suspension for injection570490.048957/26/0490.489Approved 30 April 2026RegisteredS4PIPIL
Vidaza

EACH 1,0 ml SUSPENSION CONTAINS AZACITIDINE 25,0 mg

100 mgPowder for suspension for injectionA400521A40/26/0521Approved 21 October 2022RegisteredS4PIPIL

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, 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 Azacitidine

  • S4: Azacitidine

    Consolidated Schedules 06 July 2026, line 5405

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

Schedule verified from official documents

Schedule Verification

Azacitidine DRL, Dr Reddyæs Laboratories (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsAzacitidine DRL, Dr Reddyæs Laboratories (Pty) LtdPatient information leaflet (PIL)For patients and carersAzacitidine DRL, Dr Reddyæs Laboratories (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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