Sunitinib
Sold as Sutent, Tisumor, Sunitinib cipla, Suzopa, Sutribax, Sunitinib AURO
N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide
Drag to rotate. Structure from PubChem CID 5329102.
Background
Registration
- Applicants
- 6
- Registrations
- 22
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd | Sutent | 12,5 mg, 25 mg, 50 mg | 410195, 410196, 410197 | S4 | None |
| Eurolab (Pty) Ltd | Tisumor | 12,5 mg, 25 mg, 37,5 mg, 50 mg | 550238, 550239, 550240, 550241 | S4 | None |
| Cipla Medpro (Pty) Ltd | Sunitinib cipla | 12,5, 25, 37,5, 50 | 560151, 560152, 560153, 560154 | S4 | None |
| Dr Reddyæs Laboratories (Pty) Ltd | Suzopa | 12,5, 25, 50 | 560289, 560290, 560291 | S4 | None |
| Aurogen South Africa (Pty) Ltd | Sutribax, Sunitinib AURO | 12,5 mg, 25 mg, 37,5 mg, 50 mg | 570316, 570317, 570318, 570319, 570320.316, 570322.318, 570323.319 | S4 | None |
| Aurobindo Pharma (Pty) Ltd | Sunitinib AURO | 25 mg | 570321.317 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sutent 25 MG capsule EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 25,0 mg | 25 mgCapsule | 41019541/26/0195 | Registered | S4 | None |
| Sutent 50 MG capsule EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 50,0 mg | 50 mgCapsule | 41019641/26/0196 | Registered | S4 | None |
| Sutent 12,5 MG capsule EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 12,5 mg | 12,5 mgCapsule | 41019741/26/0197 | Registered | S4 | None |
| Tisumor 12,5 MG EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 12,5 mg | 12,5 mg | 55023855/26/0238 | Registered | S4 | None |
| Tisumor 25 MG EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 25,0 mg | 25 mg | 55023955/26/0239 | Registered | S4 | None |
| Tisumor 37,5 MG EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 37,5 mg | 37,5 mg | 55024055/26/0240 | Registered | S4 | None |
| Tisumor 50 MG EACH CAPSULE CONTAINS SUNITINIB MALEATE EQUIVALENT TO SUNITINIB 50,0 mg | 50 mg | 55024155/26/0241 | Registered | S4 | None |
| Sunitinib 12,5 cipla EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 12,5 mg | 12,5 | 56015156/26/0151 | Registrered | S4 | None |
| Sunitinib 25 cipla EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 25,0 mg | 25 | 56015256/26/0152 | Registrered | S4 | None |
| Sunitinib 37,5 cipla EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 37,5 mg | 37,5 | 56015356/26/0153 | Registrered | S4 | None |
| Sunitinib 50 cipla EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 50,0 mg | 50 | 56015456/26/0154 | Registrered | S4 | None |
| Suzopa 12,5 EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 12,5 mg | 12,5 | 56028956/26/0289 | Registered | S4 | None |
| Suzopa 25 EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 25,0 mg | 25 | 56029056/26/0290 | Registered | S4 | None |
| Suzopa 50 EACH CAPSULE CONTAINS SUNITINIB MALATE EQUIVALENT TO SUNITINIB 50,0 mg | 50 | 56029156/26/0291 | Registered | S4 | None |
| Sutribax 12,5 MG capsules EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 12,5 mg | 12,5 mgCapsules | 57031657/26/0316 | Registered | S4 | None |
| Sutribax 25 MG capsules EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 25,0 mg | 25 mgCapsules | 57031757/26/0317 | Registered | S4 | None |
| Sutribax 37,5 MG capsules EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 37,5 mg | 37,5 mgCapsules | 57031857/26/0318 | Registered | S4 | None |
| Sutribax 50 MG capsules EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 50,0 mg | 50 mgCapsules | 57031957/26/0319 | Registered | S4 | None |
| Sunitinib 12,5 MG AURO EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 12,5 mg | 12,5 mg | 570320.31657/26/0320.316 | Registered | S4 | None |
| Sunitinib 25 MG AURO EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO: SUNITINIB 25,0 mg | 25 mg | 570321.31757/26/0321.317 | Registered | S4 | None |
| Sunitinib 37,5 MG AURO EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 37,5 mg | 37,5 mg | 570322.31857/26/0322.318 | Registered | S4 | None |
| Sunitinib 50 MG AURO EACH CAPSULE CONTAINS: SUNITINIB MALATE EQUIVALENT TO SUNITINIB 50,0 mg | 50 mg | 570323.31957/26/0323.319 | 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 Sunitinib maleate equivalent to sunitinib
S4: Sunitinib
Consolidated Schedules 06 July 2026, line 8064
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
SAHPRA has not published a professional information or patient information leaflet for this product.