Melphalan
Sold as Alkeran, Recrom and sterile diluent for recrom, Zalcaren and sterile diluent for zalcaren, Melpispal, Faloxeran, Melphalan hetero
(2S)-2-Amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid
Drag to rotate. Structure from PubChem CID 460612.
Background
Registration
- Applicants
- 4
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmeadCertificate held by Aspen pharmacare | Alkeran | 50, SD, 2 mg | 270506, H2744 | S4 | PIPIL |
| Aurogen South Africa (Pty) Ltd | Recrom and sterile diluent for recrom, Zalcaren and sterile diluent for zalcaren | 50 mg | 540596, 540597.596 | S4 | PIPIL |
| Mc Pharma (Pty) LtdCertificate held by Ruby Pharmaceuticals (Pty) Ltd | Melpispal | 50 mg | 550558 | S4 | PIPIL |
| Hetero Drugs South Africa (Pty) Ltd | Faloxeran, Melphalan hetero | Not stated | 560931, 560932.931 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Alkeran 50 EACH VIAL CONTAINS MELPHALAN HYDROCHLORIDE 50 mg | 50. SDPowder and solution for injection | 27050627/26/0506Approved 30 September 2021 | Registered | S4 | PIPIL |
| Recrom and sterile diluent for recrom EACH VIAL CONTAINS MELPHALAN HYDROCHLORIDE EQUIVALENT TO MELPHALAN 50,0 mg | 50 mgPowder and solvent for solution for injection/infusion | 54059654/26/0596Approved 5 July 2022 | Registered | S4 | PIPIL |
| Zalcaren and sterile diluent for zalcaren EACH VIAL CONTAINS MELPHALAN HYDROCHLORIDE EQUIVALENT TO MELPHALAN 50,0 mg | 50 mgPowder and solvent for solution for injection/infusion | 540597.59654/26/0597.596Approved 5 July 2022 | Registered | S4 | PIPIL |
| Melpispal 50 EACH VIAL CONTAINS MELPHALAN HYDROCHLORIDE 50,0 mg | 50 mgPowder and solvent for solution for injection | 55055855/26/0558Approved 18 April 2023 | Registered | S4 | PIPIL |
| Faloxeran EACH VIAL CONTAINS MELPHALAN HYDROCHLORIDE EQUIVALENT TO MELPHALAN 50,0 mg | Not listed | 56093156/26/0931 | Registered | S4 | None |
| Melphalan hetero EACH VIAL CONTAINS MELPHALAN HYDROCHLORIDE EQUIVALENT TO MELPHALAN 50,0 mg | Not listed | 560932.93156/26/0932.931 | Registered | S4 | None |
| Alkeran 2 MG EACH TABLET CONTAINS MELPHALAN 2 mg | 2 mg | H2744H/26/2744 | 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, read from the product's PI-PIL leaflet.
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 Melphalan hydrochloride
S4: Melphalan
- unless listed in another Schedule.
Consolidated Schedules 06 July 2026, line 7046
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
Alkeran 50, Pharmacare limited û woodmead 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.