Bicalutamide (Bicalutamide AURO)
Bicalutamide
Aurogen South Africa (Pty) Ltd
Registration
- Applicant
- Aurogen South Africa (Pty) Ltd
- Certificate holder
- Aurogen SA (Pty) Ltd
- Registrations
- 2
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bicalutamide 50 MG AURO EACH TABLET CONTAINS: BICALUTAMIDE 50,0 mg | 50 mgFilm-coated tablet | 59074859/21.12/0748Approved 21 July 2026 | Registered | S4 | PIPIL |
| Bicalutamide 150 MG AURO EACH TABLET CONTAINS: BICALUTAMIDE 150,0 mg | 150 mgFilm-coated tablet | 59074959/21.12/0749Approved 21 July 2026 | Registered | S4 | PIPIL |
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 Bicalutamide
S4: Bicalutamide
Consolidated Schedules 06 July 2026, line 5493
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.
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methylpropanamide
Drag to rotate. Structure from PubChem CID 2375.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.