Sunitinib malate (Tinsuneb)
Sunitinib malate
Ranbaxy Pharmaceutical (Pty) Ltd
Registration
- Applicant
- Ranbaxy Pharmaceutical (Pty) Ltd
- Certificate holder
- Ranbaxy Pharmaceuticals (Pty) Ltd
- Registrations
- 3
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Tinsuneb 12,5 EACH CAPSULE CONTAINS SUNITINIB MALATE 12,5 mg | 12,5; 25 or 50 mgHard gelatin capsules | 56093556/26/0935Approved 17 August 2025 | Registered | S4 | PIPIL |
| Tinsuneb 25 EACH CAPSULE CONTAINS SUNITINIB MALATE 25,0 mg | 12,5; 25 or 50 mgHard gelatin capsules | 56093656/26/0936Approved 17 August 2025 | Registered | S4 | PIPIL |
| Tinsuneb 50 EACH CAPSULE CONTAINS SUNITINIB MALATE 50,0 mg | 12,5; 25 or 50 mgHard gelatin capsules | 56093756/26/0937Approved 17 August 2025 | 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, 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.
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-[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.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.