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Azacitidine (Spalzact)

Azacitidine

Mc Pharma (Pty) Ltd

S4Read from the PI-PIL document and verified

Registration

Applicant
Mc Pharma (Pty) Ltd
Certificate holder
Ruby Pharmaceuticals (Pty) Ltd
Registrations
1
Schedule source
SAHPRA documentation

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Spalzact 100

EACH VIAL CONTAINS: AZACITIDINE 100,0 mg

100 mgPowder for suspension for injection55055955/26/0559Approved 13 December 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.

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.

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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