Abiraterone
Sold as Zytiga, Abiraterone 250drl, Abitig, Abarine, Teronred, Neobi, Heteran, Zybirat, Abiraterone cipla, Protyga, Zybera, Abiraterone ascend, Abizista, Alernova, Abiraterone sandoz, Enorterib, Abiraterone teva, Abitate, Prosabirat
(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.
Background
Registration
- Applicants
- 14
- Registrations
- 25
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Janssen Pharmaceutica (Pty) Ltd | Zytiga | 250 mg | 460379 | Not determined | None |
| Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd. | Abiraterone 250drl, Teronred | 250 mg, 500 mg | 500857, 510732, 560715 | S4 | PIPIL |
| Ranbaxy Pharmaceutical (Pty) Ltd | Abitig, Abarine | Not stated | 510508, 510509.508 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Neobi, Heteran, Zybirat | 250 | 511130, 511131.13, 511132.13 | S4 | None |
| Cipla Medpro (Pty) Ltd | Abiraterone cipla | Not stated | 520144 | S4 | None |
| Forrester Pharma (Pty) Ltd | Protyga | 250 mg | 520340 | S4 | PIPIL |
| Teva Pharmaceuticals (Pty) Ltd | Zybera, Abiraterone teva | 250 mg, 500 mg | 540027, 570328, 570329.328 | S4 | PIPIL |
| Ascend Laboratories (Pty) Ltd | Abiraterone ascend | 250 mg | 540825 | Not determined | None |
| Eurolab (Pty) Ltd | Abizista | 250 mg, 500 mg | 550112, 550113 | S4 | None |
| Trinity Pharma (Pty) Ltd | Alernova | 0,5 mg | 550310.309 | S2 | PIPIL |
| Sandoz South Africa (Pty) Ltd | Abiraterone sandoz | 1 000, 250, 500 | 561105, 561106, 561107 | S4 | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Enorterib | 500 mg | 570051 | S4 | PIPIL |
| Equity Pharmaceutical (Pty) Ltd | Abitate | 250, 500 | 580124, 580125 | S4 | None |
| Accord Healthcare (Pty) Ltd | Prosabirat | 500 mg | 590148 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zytiga 250 MG EACH TABLET CONTAINS ABIRATERONE 250,0 mg | 250 mg | 46037946/21.12/0379 | Registered | Not determined | None |
| Abiraterone 250drl EACH TABLET CONTAINS: ABIRATERONE ACETATE 250,0 mg | 250 mgFilm-coated tablets. | 50085750/21.12/0857Approved 28 March 2025 | Registered | S4 | PIPIL |
| Abitig Each Tablet contains: Abiraterone Acetate 250,0 mg | Not listed | 51050851/21.12/0508 | Registered | S4 | None |
| Abarine Each Tablet contains: Abiraterone Acetate 250,0 mg | Not listed | 510509.50851/21.12/0509.508 | Registered | S4 | None |
| Teronred 250 EACH TABLET CONTAINS: ABIRATERONE ACETATE 250,0 mg | 250 mgFilm-coated tablets. | 51073251/21.12/0732Approved 28 March 2025 | Registered | S4 | PIPIL |
| Neobi 250 EACH TABLET CONTAINS ABIRATERONE ACETATE 250,0 mg | 250 | 51113051/21.12/1130 | Registered | S4 | None |
| Heteran 250 EACH TABLET CONTAINS ABIRATERONE ACETATE 250,0 mg | 250 | 511131.1351/21.12/1131.130 | Registered | S4 | None |
| Zybirat 250 EACH TABLET CONTAINS ABIRATERONE ACETATE 250,0 mg | 250 | 511132.1351/21.12/1132.130 | Registered | S4 | None |
| Abiraterone cipla EACH TABLET CONTAINS ABIRATERONE ACETATE 250,0 mg | Not listed | 52014452/21.12/0144 | Registered | S4 | None |
| Protyga EACH TABLET CONTAINS: ABIRATERONE ACETATE 250,0 mg | 250 mgUncoated tablets. | 52034052/21.12/0340Approved 21 July 2023 | Registered | S4 | PIPIL |
| Zybera 250 MG EACH TABLET CONTAINS ABIRATERONE 250,0 mg | 250 mg | 54002754/21.12/0027 | Registered | Not determined | None |
| Abiraterone 250 MG ascend EACH TABLET CONTAINS ABIRATERONE 250,0 mg | 250 mg | 54082554/21.12/0825 | Registered | Not determined | None |
| Abizista 250 MG EACH TABLET CONTAINS ABIRATERONE ACETATE 250,0 mg | 250 mg | 55011255/21.12/0112 | Registered | S4 | None |
| Abizista 500 MG EACH TABLET CONTAINS ABIRATERONE ACETATE 500,0 mg | 500 mg | 55011355/21.12/0113 | Registered | S4 | None |
| Alernova 0,5 mg/ml EACH TABLET CONTAINS: ABIRATERONE ACETATE 0,5 mg | 0,5 mgOral solution | 550310.30955/5.7.1/0310.309Approved 14 February 2023 | Registered | S2 | PIPIL |
| Teronred 500 EACH TABLET CONTAINS ABIRATERONE ACETATE 500,0 mg | 500 mgFilm-coated tablets. | 56071556/21.12/0715Approved 10 March 2025 | Registered | S4 | PIPIL |
| Abiraterone 250 sandoz EACH TABLET CONTAINS ABIRATERONE ACETATE 250,0 mg | 250 | 56110556/21.12/1105 | Registered | S4 | None |
| Abiraterone 500 sandoz EACH TABLET CONTAINS ABIRATERONE ACETATE 500,0 mg | 500 | 56110656/21.12/1106 | Registered | S4 | None |
| Abiraterone 1 000 sandoz EACH TABLET CONTAINS ABIRATERONE ACETATE 1 000,0 mg | 1 000 | 56110756/21.12/1107 | Registered | S4 | None |
| Enorterib 500 MG EACH TABLET CONTAINS: ABIRATERONE ACETATE 500,0 mg | 500 mgFilm-coated tablet | 57005157/21.12/0051Approved 30 June 2026 | Registered | S4 | PIPIL |
| Zybera 500 MG EACH TABLET CONTAINS: ABIRATERONE ACETATE 500,0 mg | 500 mgFilm-coated tablet | 57032857/21.12/0328Approved 30 June 2026 | Registered | S4 | PIPIL |
| Abiraterone 500 teva EACH TABLET CONTAINS: ABIRATERONE ACETATE 500,0 mg | 500 mgFilm-coated tablet | 570329.32857/21.12/0329.328Approved 30 June 2026 | Registered | S4 | PIPIL |
| Abitate 250 EACH TABLET CONTAINS: ABIRATERONE ACETATE 250,0 mg | 250 | 58012458/21.12/0124 | Registered | S4 | None |
| Abitate 500 EACH TABLET CONTAINS: ABIRATERONE ACETATE 500,0 mg | 500 | 58012558/21.12/0125 | Registered | S4 | None |
| Prosabirat 500 MG EACH TABLET CONTAINS: ABIRATERONE ACETATE 500,0 mg | 500 mg | 59014859/21.12/0148 | Registered | S4 | None |
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 Abiraterone acetate
S4: Abiraterone
Consolidated Schedules 06 July 2026, line 5131
Pharmacological class: Hormone inhibitors. (class 21.12)
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 Verification
Abiraterone 250drl, Dr Reddyæs Laboratories (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.