Busulfan
Sold as Busilvex, Busulfan fresenius, Vexfan, Detener, Meliora, Myleran
4-Methylsulfonyloxybutyl methanesulfonate
Drag to rotate. Structure from PubChem CID 2478.
Background
Registration
- Applicants
- 5
- Registrations
- 6
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pierre Fabre South Africa (Pty) LtdCancelled | Busilvex | Not stated | 370668 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Busulfan fresenius | 6 mg | 490087 | S4 | PIPIL |
| Eurolab (Pty) LtdCertificate held by Eurolab (Pty) Ltd. | Vexfan | 6mg | 550347 | S4 | PIPIL |
| Emcure- Pharmaceutical South Africa (Pty) LtdCertificate held by Emcure Pharmaceuticals SA (Pty) Ltd | Detener, Meliora | 60,0 mg | 560353, 560354.353 | S4 | PIPIL |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited | Myleran | 2 mg | H2750 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Busilvex EACH AMPOULE CONTAINS BUSULFAN 60,0 mg | Not listed | 37066837/26/0668 | Cancelled | S4 | None |
| Busulfan 6 MG /ml fresenius | 6 mgConcentrate for solution for infusion | 49008749/26/0087Approved 11 October 2023 | Registered | S4 | PIPIL |
| Vexfan | 6mgSolution for infusion | 55034755/26/0347Approved 6 April 2022 | Registered | S4 | PIPIL |
| Detener EACH 10,0 ml SOLUTION CONTAINS BUSULFAN 60,0 mg | 60,0 mgConcentrate for solution for infusion | 56035356/26/0353Approved 24 January 2023 | Registered | S4 | PIPIL |
| Meliora BUSULFAN | 60,0 mgConcentrate for solution for infusion | 560354.35356/26/0354.353Approved 24 January 2023 | Registered | S4 | PIPIL |
| Myleran | 2 mgFilm-coated tablets | H2750Approved 5 March 2020 | Old Medicine | 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 Busulfan
S4: Busulfan
Consolidated Schedules 06 July 2026, line 5592
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
Busulfan 6 MG /ml fresenius, Fresenius Kabi South Africa (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.