Rituximab
Sold as Mabthera, Ristova, Mabthera sc, Blitzima, Rixathon, Rituximab equity, Rituxima cipla
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 5
- Registrations
- 13
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Roche Products (Pty) LtdCertificate held by Roche | Mabthera, Ristova, Mabthera sc | 100, 120 mg, 500 | 320578, 320579, 460868, 460869, 490466 | S4 | PIPIL |
| Adcock ingram limited | Blitzima | 100 mg, 500 mg | 530506, 530507 | S4 | None |
| Sandoz South Africa (Pty) Ltd | Rixathon | 100 mg/10 ml, 500 mg/50 ml | 550405, 550406 | S4 | None |
| Equity Pharmaceutical (Pty) LtdCertificate held by Equity Pharmaceuticals (Pty) Ltd | Rituximab equity | 100, 500 | 56/26/0485, 560484 | S4 | PIPIL |
| Cipla Medpro (Pty) Ltd | Rituxima cipla | 100, 500 | 570217, 570218 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mabthera 100 EACH 1,0 ml SOLUTION CONTAINS RITUXIMAB 10,0 mg | 100Infusion | 32057832/26/0578Approved 2 October 2015 | Registered | S4 | PIPIL |
| Mabthera 500 EACH 1,0 ml SOLUTION CONTAINS RITUXIMAB 10,0 mg | 500Infusion | 32057932/26/0579Approved 2 October 2015 | Registered | S4 | PIPIL |
| Ristova 100 EACH VIAL CONTAINS RITUXIMAB 100,0 mg | 100 | 46086846/26/0868 | Registered | S4 | None |
| Ristova 500 EACH VIAL CONTAINS RITUXIMAB 500,0 mg | 500 | 46086946/26/0869 | Registered | S4 | None |
| Mabthera sc 1400 MG EACH VIAL CONTAINS RITUXIMAB 1 400,0 mg | 120 mgSolution for subcutaneous injection | 49046649/30.1/0466Approved 11 October 2023 | Registered | S4 | PIPIL |
| Blitzima 100 MG EACH 50,0 ml SOLUTION CONTAINS RITUXIMAB 100,0 mg | 100 mg | 53050653/26/0506 | Registered | S4 | None |
| Blitzima 500 MG EACH 50,0 ml SOLUTION CONTAINS RITUXIMAB 500,0 mg | 500 mg | 53050753/26/0507 | Registered | S4 | None |
| Rixathon 100 mg/10 ML EACH 10,0 ml SOLUTION CONTAINS RITUXIMAB 100,0 mg | 100 mg/10 ml | 55040555/26/0405 | Registered | S4 | None |
| Rixathon 500 mg/50 ML EACH 50,0 ml SOLUTION CONTAINS RITUXIMAB 500,0 mg | 500 mg/50 ml | 55040655/26/0406 | Registered | S4 | None |
| Rituximab 500 equity Each vial contains: Rituximab 500,0 mg | 500Solution for infusion | 56/26/0485Approved 3 June 2025 | Registered | S4 | PIPIL |
| Rituximab 100 equity Each vial contains: Rituximab 100,0 mg | 100Solution for infusion | 56048456/26/0484Approved 3 June 2025 | Registered | S4 | PIPIL |
| Rituxima 100 cipla Each vial contains: Rituximab 100,0 mg | 100 | 57021757/30.1/0217 | Registered | S4 | None |
| Rituxima 500 cipla Each vial contains: Rituximab 500,0 mg | 500 | 57021857/30.1/0218 | 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 Rituximab
S4: Rituximab
Consolidated Schedules 06 July 2026, line 7822
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.