Rivaroxaban (Rezalto, Rivaroxaban Austell)
Rivaroxaban
Austell Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Austell Pharmaceuticals (Pty) Ltd
- Certificate holder
- Austell Pharmaceuticals (Pty) Ltd
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Rezalto 10 MG EACH TABLET CONTAINS RIVAROXABAN 10,0 mg | 10 mgFilm-coated tablet. | 53019453/8.2/0194Approved 3 November 2020 | Registered | S4 | PIPIL |
| Rezalto 15 MG EACH TABLET CONTAINS RIVAROXABAN 15,0 mg | 15 mg | 53019553/8.2/0195 | Registered | S4 | None |
| Rezalto 20 MG EACH TABLET CONTAINS RIVAROXABAN 20,0 mg | 20 mg | 53019653/8.2/0196 | Registered | S4 | None |
| Rivaroxaban 10 MG austell EACH TABLET CONTAINS RIVAROXABAN 10,0 mg | 10 mg | 530197.19453/8.2/0197.194 | Registered | S4 | None |
| Rivaroxaban 15 MG austell EACH TABLET CONTAINS RIVAROXABAN 15,0 mg | 15 mg | 530198.19553/8.2/0198.195 | Registered | S4 | None |
| Rivaroxaban 20 MG austell EACH TABLET CONTAINS RIVAROXABAN 20,0 mg | 20 mg | 530199.19653/8.2/0199.196 | 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, 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 Rivaroxaban
S4: Rivaroxaban
Consolidated Schedules 06 July 2026, line 7824
Pharmacological class: Anticoagulants. (class 8.2)
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.
5-Chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide
Drag to rotate. Structure from PubChem CID 9875401.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.