Beduras
4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 65628.
Registration
- Applicants
- 1
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Beduras 25 MG Each vial contains: Bendamustine Hydrochloride 25,0 mg | 25 mgPowder for concentrate for solution for infusion | 56112356/26/1123Approved 12 August 2025 | Registered | S4 | PIPIL |
| Beduras 100 MG Each vial contains: Bendamustine Hydrochloride 100,0 mg | 100 mgPowder for concentrate for solution for infusion | 56112456/26/1124Approved 12 August 2025 | 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, 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 Bendamustine hydrochloride
S4: Bendamustine
Consolidated Schedules 06 July 2026, line 5457
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.
Background
SAHPRA documents
Schedule Verification
Beduras 25 MG, Pharma-q Holdings (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents come from SAHPRA's PI-PIL repository unless the line under a document says otherwise. Always consult with a healthcare professional for medical advice.