Mitoxantrone
Sold as Hx-mitoxantrone, Mitoxantrone hexal, Mitoxantron "ebewe"
1,4-Dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthracene-9,10-dione
Drag to rotate. Structure from PubChem CID 4212.
Background
Registration
- Applicants
- 2
- Registrations
- 4
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sandoz South Africa (Pty) Ltd1 of 2 cancelled | Hx-mitoxantrone, Mitoxantrone hexal | 20 mg/10 ml, 20 mg/10 ml - | 370103, 370168 | S4 | None |
| Key Oncologics (Pty) LtdCancelled | Mitoxantron "ebewe" | 10 mg, 20 mg | 410415, 410416 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Hx-mitoxantrone 20 mg/10 ML EACH 1,0 ml SOLUTION CONTAINS MITOXANTRONE HYDROCHLORIDE 2,328 mg | 20 mg/10 ml | 37010337/26/0103 | Cancelled | S4 | None |
| Mitoxantrone - hexal 20 mg/10 ML EACH 1,0 ml SOLUTION CONTAINS MITOXANTRONE HYDROCHLORIDE 2,328 mg | 20 mg/10 ml - | 37016837/26/0168 | Registered | S4 | None |
| Mitoxantron "ebewe" 10 MG EACH VIAL CONTAINS MITOXANTRONE HYDROCHLORIDE EQUIVALENT TO MITOXANTRONE 10,0 mg | 10 mg | 41041541/26//415 | Cancelled | S4 | None |
| Mitoxantron "ebewe" 20 MG EACH VIAL CONTAINS MITOXANTRONE HYDROCHLORIDE EQUIVALENT TO MITOXANTRONE 20,0 mg | 20 mg | 41041641/26/0416 | Cancelled | 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 Mitoxantrone hydrochloride
S4: Mitoxantrone
Consolidated Schedules 06 July 2026, line 7155
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.