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Roxadustat (Evrenzo)

Roxadustat

Astellas Pharma (Pty) Ltd

S4

Registration

Applicant
Astellas Pharma (Pty) Ltd
Registrations
5
Schedule source
Consolidated Schedules 06 July 2026

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Evrenzo 20 MG

EACH TABLET CONTAINS ROXADUSTAT 20,0 mg

20 mg55041755/8.5/0417RegisteredS4None
Evrenzo 50 MG

EACH TABLET CONTAINS ROXADUSTAT 50,0 mg

50 mg55041855/8.5/0418RegisteredS4None
Evrenzo 70 MG

EACH TABLET CONTAINS ROXADUSTAT 70,0 mg

70 mg55041955/8.5/0419RegisteredS4None
Evrenzo 100 MG

EACH TABLET CONTAINS ROXADUSTAT 100,0 mg

100 mg55042055/8.5/0420RegisteredS4None
Evrenzo 150 MG

EACH TABLET CONTAINS ROXADUSTAT 150,0 mg

150 mg55042155/8.5/0421RegisteredS4None

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 Roxadustat

  • S4: Roxadustat

    Consolidated Schedules 06 July 2026, line 7857

Pharmacological class: Others. (class 8.5)

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.

C19H16N2O5352.30 g/mol

2-[(4-Hydroxy-1-methyl-7-phenoxyisoquinoline-3-carbonyl)amino]acetic acid

Drag to rotate. Structure from PubChem CID 11256664.

SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Background

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Research articles

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