Palonosetron
Sold as Palonosetron teva, Nocipal, Bevativa, Tronson, Palonosetron fresenius, Palton, Kemoprev iv, Loxonext, Poltazo, Hetnoset, Chemsentron, Palonosetron ascendis, Onicit
(3AS)-2-[(3S)-1-azabicyclo[2.2.2]octan-3-yl]-3a,4,5,6-tetrahydro-3H-benzo[de]isoquinolin-1-one
Drag to rotate. Structure from PubChem CID 6337614.
Background
Registration
- Applicants
- 11
- Registrations
- 13
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Teva Pharmaceuticals (Pty) Ltd | Palonosetron teva | 0,25 mg | 491130 | Not determined | PIPIL |
| Cipla Medpro (Pty) Ltd | Nocipal | 250 μg/ 5 mL | 500752 | Not determined | PIPIL |
| Macleods Pharmaceuticals SA (Pty) Ltd | Bevativa | Not stated | 510250 | Not determined | None |
| Eurolab (Pty) LtdCancelled | Tronson | Not stated | 520020 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Palonosetron fresenius | 0,05 mg/mL | 520099 | S4 | PIPIL |
| Activo Health (Pty) Ltd | Palton | Not stated | 520344 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Kemoprev iv | 250 μg | 530647 | S4 | PIPIL |
| Hetero Drugs South Africa (Pty) Ltd | Loxonext, Poltazo, Hetnoset | Not stated | 540289, 540290.289, 540291.289 | Not determined | None |
| Juno Pharma SA (Pty) LtdCertificate held by Kahma Biotech (Pty) Ltd | Chemsentron | 250,0 μg | 550344 | S4 | PIPIL |
| Ascendis Pharma (Pty) Ltd | Palonosetron ascendis | 250 | 560440 | Not determined | None |
| Biomab Innovation (Pty) LtdCertificate held by Pfizer Laboratories (Pty) Ltd | Onicit | 1ML / 5ML | A400322 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Palonosetron 0,25 teva Each vial of 5 ml of solution contains PALONOSETRON (AS HYDROCHLORIDE) 0,25 mg | 0,25 mgSolution for injection; | 49113049/5.10/1130Approved 23 February 2023 | Registered | Not determined | PIPIL |
| Nocipal | 250 μg/ 5 mLSolution for injection | 50075250/5.10/0752Approved 9 December 2022 | Registered | Not determined | PIPIL |
| Bevativa EACH 5,0 ml VIAL CONTAINS PALONOSETRON (AS HYDROCHLORIDE) 0,25 mg | Not listed | 51025051/5.10/0250 | Registered | Not determined | None |
| Tronson EACH 5,0 ml SOLUTION CONTAINS PALONOSETRON HYDROCHLORIDE 250,0 ug | Not listed | 52002052/5.10/0020 | Cancelled | S4 | None |
| Palonosetron 0,05 mg/ml fresenius | 0,05 mg/mLSolution for injection | 52009952/5.10/0099Approved 12 April 2022 | Registered | S4 | PIPIL |
| Palton Each 5ml contains PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON 250,0 mcg | Not listed | 52034452/5.10/0344 | Registered | Not determined | None |
| Kemoprev iv PALONOSETRON HYDROCHLORIDE | 250 μgSolution for injection or infusion | 53064753/5.10/0647Approved 21 February 2023 | Registered | S4 | PIPIL |
| Loxonext EACH VIAL CONTAINS PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON 0,25 mg | Not listed | 54028954/5.10/0289 | Registered | Not determined | None |
| Poltazo EACH VIAL CONTAINS PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON 0,25 mg | Not listed | 540290.28954/5.10/0290.289 | Registered | Not determined | None |
| Hetnoset EACH VIAL CONTAINS PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON 0,25 mg | Not listed | 540291.28954/5.10/0291.289 | Registered | Not determined | None |
| Chemsentron PALONOSETRON HYDROCHLORIDE | 250,0 μgSolution for injection | 55034455/5.10/0344Approved 29 November 2022 | Registered | S4 | PIPIL |
| Palonosetron 250 ascendis EACH 5,0 ml SOLUTION CONTAINS PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON 250,0 µg | 250 | 56044056/5.10/0440 | Registered | Not determined | None |
| Onicit EACH 1,0 ml SOLUTION CONTAINS PALONOSETRON HYDROCHLORIDE EQUIVALENT TO PALONOSETRON 50,0 ug | 1ML / 5MLSolution for injection | A400322A40/5.10/0322Approved 13 June 2014 | 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, 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 Palonosetron hydrochloride
S4: Palonosetron
Consolidated Schedules 06 July 2026, line 7461
Pharmacological class: Serotonin antagonists. (class 5.10)
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.