Irinotecan
Sold as Campto, Sandoz irinotecan, Irenax, Cipla-irinotecan, Irinotas, Accord irinotecan, Irinotecan viatris, Campto csv, Irnocam, Irinotecan safeline, Irinotecan, Irinotecan FKSA, Colocam, Emcure irinotecan, Irocan, * tiracamp, Iritero, Carohet, Onivyde
[(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.
Background
Registration
- Applicants
- 16
- Registrations
- 42
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) LtdCancelled | Campto, Campto csv | 100 mg/5 ml, 300 mg/15 ml | 310183, 431067 | S4 | None |
| Oethmaan Biosims (Pty) Ltd | Sandoz irinotecan | 40, 100 | 410028, 410029 | S4 | None |
| Sandoz South Africa (Pty) LtdCancelled | Irenax | 40, 100 | 410030, 410031 | S4 | None |
| Cipla Medpro (Pty) Ltd | Cipla-irinotecan | 40 mg/2 ml, 100 mg/5 ml | 410049, 410050 | S4 | None |
| Eurolab (Pty) Ltd | Irinotas | 40, 100 | 411003, 440024 | S4 | None |
| Accord Healthcare (Pty) Ltd | Accord irinotecan | 40, 100 | 411004, 440025 | S4 | None |
| Viatris South Africa (Pty) Ltd | Irinotecan viatris | 40 mg/2 ml, 100 mg/5 ml | 430348, 430349 | S4 | None |
| Dr Reddyæs Laboratories (Pty) LtdCancelled | Irnocam | 100 | 440587 | S4 | None |
| Safeline Pharmaceuticals (Pty) LtdCancelled | Irinotecan safeline, Irinotecan | 40 mg/2 ml, 100 mg/5 ml | 450383, 450384 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Irinotecan FKSA | 40 mg/2 ml, 100 mg/5 ml, 300 mg/15 ml, 500 mg/25 ml | 450915, 450916, 450917, 450918 | S4 | None |
| Equity Pharmaceutical (Pty) LtdCertificate held by Equity pharmaceuticals | Colocam | 40, 100, 300, 500 | 460271, 460272, 460273, 460274 | S4 | PIPIL |
| Emcure- Pharmaceutical South Africa (Pty) LtdCancelled | Emcure irinotecan | 40 mg/2 ml, 100 mg/5 ml | 460731, 460732 | S4 | None |
| Innovata pharmaceuticals | Irocan | 40 mg/2 ml, 100 mg/5 ml, 300 mg/15 ml, 500 mg/25 ml | 500947, 500948, 500949, 500950 | S4 | None |
| Mc Pharma (Pty) Ltd | * tiracamp | 40, 100, 300, 500 | 550428, 550429, 550430, 550431 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Iritero, Carohet | 40 mg/2 ml, 100 mg/5 ml, 300 mg/5 ml, 300 mg/15 ml | 560829, 560830, 560831, 560832.829, 560833.830, 560834.831 | S4 | None |
| Servier Laboratories South Africa (Pty) Ltd | Onivyde | Not stated | 570867 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Campto 100 mg/5 ML EACH 5 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE (TRIHYDRATE) EQUIVALENT TO 100 mg IRINOTECAN | 100 mg/5 ml | 31018331/26/0183 | Cancelled | S4 | None |
| Sandoz irinotecan 40 EACH 2,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40,0 mg | 40 | 41002841/26/0028 | Registered | S4 | None |
| Sandoz irinotecan 100 EACH 5,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 100,0 mg | 100 | 41002941/26/0029 | Registered | S4 | None |
| Irenax 40 EACH 2,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40,0 mg | 40 | 41003041/26/0030 | Cancelled | S4 | None |
| Irenax 100 EACH 5,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 100,0 mg | 100 | 41003141/26/0031 | Cancelled | S4 | None |
| Cipla-irinotecan 40 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 40,0 mg | 40 mg/2 ml | 41004941/26/0049 | Registered | S4 | None |
| Cipla-irinotecan 100 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 100,0 mg | 100 mg/5 ml | 41005041/26/0050 | Registered | S4 | None |
| Irinotas 40 EACH 2,0 ml VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 40,0 mg | 40 | 41100341/26/1003 | Registered | S4 | None |
| Accord irinotecan 40 EACH 2,0 ml VIAL CONTAINS: IRINOTECAN HYDROCHLORIDE 40,0 mg | 40 | 41100441/26/1004 | Registered | S4 | None |
| Irinotecan 100 mg/5 ML viatris EACH 5,0 ml VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 100,0 mg | 100 mg/5 ml | 43034843/26/0348 | Registered | S4 | None |
| Irinotecan 40 mg/2 ML viatris EACH 2,0 ml VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 40,0 mg | 40 mg/2 ml | 43034943/26/0349 | Registered | S4 | None |
| Campto csv 300 mg/15 ML EACH 1,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE 20,0 mg | 300 mg/15 ml | 43106743/26/1067 | Cancelled | S4 | None |
| Irinotas 100 EACH 5,0 ml VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 100,0 mg | 100 | 44002444/26/0024 | Registered | S4 | None |
| Accord irinotecan 100 EACH 5,0 ml VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 100,0 mg | 100 | 44002544/26/0025 | Registered | S4 | None |
| Irnocam 100 EACH 5,0 mL VIAL CONTAINS IRINOTECAN HYDROCHLORIDE A 100,0 mg | 100 | 44058744/26/0587 | Cancelled | S4 | None |
| Irinotecan safeline 40 mg/2 ML EACH VIAL CONTAINS IRINOTECAN HYDROCHLORIDE EQUIVALENT TO IRINOTECAN 40,0 mg | 40 mg/2 ml | 45038345/26/0383 | Cancelled | S4 | None |
| Irinotecan 100 mg/5 ML EACH VIAL CONTAINS IRINOTECAN HYDROCHLORIDE EQUIVALENT TO IRINOTECAN 100,0 mg | 100 mg/5 ml | 45038445/26/0384 | Cancelled | S4 | None |
| 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 |
| Colocam 40 EACH VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 40,0 mg | 40Infusion | 46027146/26/0271Approved 30 September 2016 | Registered | S4 | PIPIL |
| Colocam 100 EACH VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 100,0 mg | 100Infusion | 46027246/26/0272Approved 30 September 2016 | Registered | S4 | PIPIL |
| Colocam 300 EACH VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 300,0 mg | 300Infusion | 46027346/26/0273Approved 30 September 2016 | Registered | S4 | PIPIL |
| Colocam 500 EACH VIAL CONTAINS IRINOTECAN HYDROCHLORIDE 500,0 mg | 500Infusion | 46027446/26/0274Approved 30 September 2016 | Registered | S4 | PIPIL |
| Emcure irinotecan 40 mg/2 ML EACH VIAL CONTAINS IRINOTECAN 40,0 mg | 40 mg/2 ml | 46073146/26/0731 | Cancelled | S4 | None |
| Emcure irinotecan 100 mg/5 ML EACH VIAL CONTAINS IRINOTECAN 100,0 mg | 100 mg/5 ml | 46073246/26/0732 | Cancelled | S4 | None |
| Irocan 40 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS :IRINOTECAN 40,0 mg | 40 mg/2 ml | 50094750/26/0947 | Registered | S4 | None |
| Irocan 100 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS: IRINOTECAN 100,0 mg | 100 mg/5 ml | 50094850/26/0948 | Registered | S4 | None |
| Irocan 300 mg/15 ML EACH 15,0 ml SOLUTION CONTAINS :IRINOTECAN 300,0 mg | 300 mg/15 ml | 50094950/26/0949 | Registered | S4 | None |
| Irocan 500 mg/25 ML EACH 25,0 ml SOLUTION CONTAINS :IRINOTECAN 500,0 mg | 500 mg/25 ml | 50095050/26/0950 | Registered | S4 | None |
| * tiracamp 40 EACH VIAL CONTAINS: IRINOTECAN HYDROCHLORIDE 40,0 mg | 40 | 55042855/26/0428 | Registered | S4 | None |
| * tiracamp 100 EACH VIAL CONTAINS: IRINOTECAN HYDROCHLORIDE 100,0 mg | 100 | 55042955/26/0429 | Registered | S4 | None |
| * tiracamp 300 EACH VIAL CONTAINS: IRINOTECAN HYDROCHLORIDE 300,0 mg | 300 | 55043055/26/0430 | Registered | S4 | None |
| * tiracamp 500 EACH VIAL CONTAINS: IRINOTECAN HYDROCHLORIDE 500,0 mg | 500 | 55043155/26/0431 | Registered | S4 | None |
| Iritero 40 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40,0 mg | 40 mg/2 ml | 56082956/26/0829 | Registered | S4 | None |
| Iritero 100 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 100,0 mg | 100 mg/5 ml | 56083056/26/0830 | Registered | S4 | None |
| Iritero 300 mg/5 ML EACH 15,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 300,0 mg | 300 mg/5 ml | 56083156/26/0831 | Registered | S4 | None |
| Carohet 40 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 40,0 mg | 40 mg/2 ml | 560832.82956/26/0832.829 | Registered | S4 | None |
| Carohet 100 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 100,0 mg | 100 mg/5 ml | 560833.83056/26/0833.830 | Registered | S4 | None |
| Carohet 300 mg/15 ML EACH 15,0 ml SOLUTION CONTAINS IRINOTECAN HYDROCHLORIDE TRIHYDRATE 300,0 mg | 300 mg/15 ml | 560834.83156/26/0834.831 | Registered | S4 | None |
| Onivyde EACH 1,0 ml OF CONCENTRATE CONTAINS: IRINOTECAN SUCROSOFATE EQUIVALENT TO IRINOTECAN ANHYDROUS 4,3 mg | Not listed | 57086757/26/0867 | 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 equivalent to irinotecan
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.
SAHPRA documents
Schedule Verification
Colocam 40, Equity Pharmaceutical (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.