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Abiraterone (Zytiga, Akeega)

Abiraterone

Janssen Pharmaceutica (Pty) Ltd

Registration

Applicant
Janssen Pharmaceutica (Pty) Ltd
Registrations
3

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Zytiga 250 MG

EACH TABLET CONTAINS ABIRATERONE 250,0 mg

250 mg46037946/21.12/0379RegisteredNot determinedNone
Akeega 50 mg/500 MG

EACH TABLET CONTAINS NIRAPARIB TOSYLATE MONOHYDRATE EQUIVALENT TO NIRAPARIB 50,0 mg ABIRATERONE ACETATE EQUIVALENT TO ABIRATERONE 500,0 mg

50 mg/500 mg59011959/26/0119RegisteredNot determinedNone
Akeega 100 mg/500 MG

EACH TABLET CONTAINS NIRAPARIB TOSYLATE MONOHYDRATE EQUIVALENT TO NIRAPARIB 100,0 mg ABIRATERONE ACETATE EQUIVALENT TO ABIRATERONE 500,0 mg

100 mg/500 mg59012059/26/0120RegisteredNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

Listings for this ingredient that could not be applied to this product

  • S4: Abiraterone

    Consolidated Schedules 06 July 2026, line 5131

  • S4: Niraparib

    Consolidated Schedules 06 July 2026, line 7281

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.

C24H31NO349.50 g/mol

(3S,8R,9S,10R,13S,14S)-10,13-Dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-ol

Drag to rotate. Structure from PubChem CID 132971.

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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