Fludarabine
Sold as Fludara, Fludarabine teva, Purida, Cipla fludarabine
[(2R,3S,4S,5R)-5-(6-Amino-2-fluoropurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl dihydrogen phosphate
Drag to rotate. Structure from PubChem CID 30751.
Background
Registration
- Applicants
- 3
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sanofi-aventis South Africa (Pty) LtdCancelled | Fludara | oral | 280605, 360422 | S4 | None |
| Teva Pharmaceuticals (Pty) LtdCertificate held by Teva Pharmaceuticals (Pty) Ltd. | Fludarabine teva | 2 ml | 430009 | S4 | PIPIL |
| Cipla Medpro (Pty) LtdCancelled | Purida, Cipla fludarabine | Not stated | 450145, 450146 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Fludara EACH 2,0 ml SOLUTION CONTAINS FLUDARABINE PHOSPHATE 50,0 mg | Not listed | 28060528/26/0605 | Cancelled | S4 | None |
| Fludara oral EACH TABLET CONTAINS FLUDARABINE PHOSPHATE 10,0 mg | Oral | 36042236/26/0422 | Cancelled | S4 | None |
| Fludarabine 50 teva EACH 2,0 ml VIAL CONTAINS FLUDARABINE PHOSPHATE 50,0 mg | 2 mlConcentrate for solution for injection or infusion | 43000943/26/0009Approved 29 April 2026 | Registered | S4 | PIPIL |
| Purida EACH VIAL CONTAINS FLUDARABINE PHOSPHATE 50,0 mg | Not listed | 45014545/26/0145 | Cancelled | S4 | None |
| Cipla fludarabine EACH VIAL CONTAINS FLUDARABINE PHOSPHATE 50,0 mg | Not listed | 45014645/26/0146 | 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 Fludarabine phosphate
S4: Fludarabine
Consolidated Schedules 06 July 2026, line 6359
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.