Irinotecan (Irinotecan FKSA)
Irinotecan
Fresenius Kabi South Africa (Pty) Ltd
Registration
- Applicant
- Fresenius Kabi South Africa (Pty) Ltd
- Registrations
- 4
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Irinotecan FKSA 40 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 40,0 mg | 40 mg/2 ml | 45091545/26/0915 | Registered | S4 | None |
| Irinotecan FKSA 100 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 100,0 mg | 100 mg/5 ml | 45091645/26/0916 | Registered | S4 | None |
| Irinotecan FKSA 300 mg/15 ML EACH 15,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 300,0 mg | 300 mg/15 ml | 45091745/26/0917 | Registered | S4 | None |
| Irinotecan FKSA 500 mg/25 ML EACH 25,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 500,0 mg | 500 mg/25 ml | 45091847/26/0918 | 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 Irinotecan hydrochloride
S4: Irinotecan
Consolidated Schedules 06 July 2026, line 6806
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.
[(19S)-10,19-Diethyl-19-hydroxy-14,18-dioxo-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-7-yl] 4-piperidin-1-ylpiperidine-1-carboxylate
Drag to rotate. Structure from PubChem CID 60838.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.