Bendamustine (Mianda, Milanda, Bendamustine Accord)
Bendamustine
Accord Healthcare (Pty) Ltd
Registration
- Applicant
- Accord Healthcare (Pty) Ltd
- Certificate holder
- Accord Healthcare (Pty) Ltd
- Registrations
- 3
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Mianda 25 | 25Powder for concentrate for solution for infusion. | 52043352/26/0433Approved 4 August 2020 | Registered | S4 | PIPIL |
| Milanda 25 solution for injection Each 1,0 ml Solution contains: Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride 25,0 mg | 25Solution for injection | 570197 | Registered | S4 | None |
| Bendamustine 25 solution for injection accord Each 1,0 ml Solution contains: Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride 25,0 mg | 25Solution for injection | 570198.19757/26/0198.197 | 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, 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 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.
4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid
Drag to rotate. Structure from PubChem CID 65628.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.