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Enzalutamide

Sold as Xtandi, Enzutix, Dizalet, Dizalum, Zilade, Enzalutamide cipla, Nuxtand, Xzalu, Enlutoza

S4
Loading the molecular structure
C21H16F4N4O2S464.40 g/mol

4-[3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl]-2-fluoro-N-methylbenzamide

Drag to rotate. Structure from PubChem CID 15951529.

Background

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Registration

Applicants
5
Registrations
9
Schedule source
Consolidated Schedules 06 July 2026

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Astellas Pharma (Pty) LtdXtandi40 mg480404S4None
Eurolab (Pty) LtdEnzutix40 mg550125S4PIPIL
Aurogen South Africa (Pty) LtdDizalet, Dizalum, Zilade40mg550174, 550175.174, 550176.174S4PIPIL
Cipla Medpro (Pty) LtdEnzalutamide cipla, Nuxtand, Xzalu40 mg550833, 560920, 560921.920S4PIPIL
Dr Reddyæs Laboratories (Pty) LtdEnlutozaNot stated580123S4None

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Xtandi 40 MG

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

40 mg48040448/26/0404RegisteredS4None
Enzutix

ENZALUTAMIDE

40 mgCapsule55012555/26/0125Approved 24 January 2023RegisteredS4PIPIL
Dizalet

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

40mgCapsules55017455/26/0174Approved 24 April 2024RegisteredS4PIPIL
Dizalum

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

40mgCapsules550175.17455/26/0175.174Approved 24 April 2024RegisteredS4PIPIL
Zilade

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

40mgCapsules550176.17455/26/0176.174Approved 24 April 2024RegisteredS4PIPIL
Enzalutamide 40 MG cipla

ENZALUTAMIDE

40 mgCapsule55083355/26/0833Approved 7 February 2023RegisteredS4PIPIL
Nuxtand

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

40 mgCapsule56092056/26/0920Approved 14 March 2023RegisteredS4PIPIL
Xzalu

EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg

40 mgCapsule560921.92056/26/0921.920Approved 14 March 2023RegisteredS4PIPIL
Enlutoza

EACH CAPSULE CONTAINS: ENZALUTAMIDE 40,0 mg

Not listed58012358/26/0123RegisteredS4None

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 Enzalutamide

  • S4: Enzalutamide

    Consolidated Schedules 06 July 2026, line 6199

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

Enzutix, Eurolab (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsEnzutix, Eurolab (Pty) LtdPatient information leaflet (PIL)For patients and carersEnzutix, Eurolab (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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