Doxorubicin
Sold as Doxorubicin hcl-faulding, Bio-doxorubicin hydrochloride, Caelyx, Adriblastina csv, Hx-doxorubicin, Cipla-doxorubicin, Doxolip, Doxorubicin accord, Rubexet, Rubidoks, Doxred lyophilized, Doxorubicin "ebewe", Doxopeg, Adriblastina rd, Doxorubicin-sol pch
(7S,9S)-7-[(2R,4S,5S,6S)-4-Amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-9-(2-hydroxyacetyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione
Drag to rotate. Structure from PubChem CID 31703.
Background
Registration
- Applicants
- 10
- Registrations
- 33
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) LtdCancelled | Doxorubicin hcl-faulding, Adriblastina csv, Adriblastina rd | 10 mg, 10 mg/5 ml, 20 mg, 50 mg, 50 mg/25 ml | 290672, 290673, 330102, 330104, F0274, F0289, U0183 | S4 | None |
| Zimbili Pharma CC | Bio-doxorubicin hydrochloride | 10, 50 | 320507, 320508 | S4 | None |
| Baxter Healthcare South Africa (Pty) LtdCertificate held by Janssen Pharmaceutica (Pty.) Ltd. | Caelyx | 2 mg/mL | 320533 | S4 | PIPIL |
| Oethmaan Biosims (Pty) Ltd | Hx-doxorubicin, Doxred lyophilized | 10 mg/ 5 ml, 10, 50 mg/ 25 ML, 50 | 370030, 370031, 570698, 570699 | S4 | None |
| Cipla Medpro (Pty) LtdCertificate held by Cipla | Cipla-doxorubicin | 10, 50 | 410034, 410035 | S4 | PIPIL |
| Ranbaxy Pharmaceutical (Pty) Ltd | Doxolip | Not stated | 430018 | S4 | None |
| Accord Healthcare (Pty) Ltd | Doxorubicin accord, Rubexet | 10 mg/5 ml, 50 mg/25 ml, 200 mg/100 ml | 460484, 460485, 460487, 460488, 460489 | S4 | None |
| Innovata pharmaceuticals | Rubidoks | 10 mg, 20 mg, 50 mg, 100 mg, 200 mg | 530077, 530078, 530079, 530080, 530081 | S4 | None |
| Key Oncologics (Pty) Ltd2 of 3 cancelled | Doxorubicin "ebewe", Doxopeg | 2 mg, 10 mg, 50 mg | A400352, A400353, A400389 | S4 | PIPIL |
| Teva Pharmaceuticals (Pty) Ltd | Doxorubicin-sol pch | 10 mg, 50 mg, 200 mg | Z0167, Z0169, Z0170 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Doxorubicin hcl-faulding 10 MG EACH 2 ml CONTAINS DOXORUBICIN HYDROCHLORIDE 10 mg | 10 mg | 29067229/26/0672 | Cancelled | S4 | None |
| Doxorubicin hcl-faulding 50 MG EACH VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50 mg | 29067329/26/0673 | Cancelled | S4 | None |
| Bio-doxorubicin hydrochloride 10 EACH 10 ml VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10 | 32050732/26/0507 | Registered | S4 | None |
| Bio-doxorubicin hydrochloride 50 EACH 37 ml VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50 | 32050832/26/0508 | Registered | S4 | None |
| Caelyx EACH 1,0 ml CONCENTRATE CONTAINS DOXORUBICIN HYDROCHLORIDE 2,0 mg | 2 mg/mLConcentrate for infusion | 32053332/26/0533Approved 27 October 2020 | Registered | S4 | PIPIL |
| Adriblastina csv 10 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/5 ml | 33010233/26/0102 | Cancelled | S4 | None |
| Adriblastina csv 50 mg/25 ML EACH 25,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/25 ml | 33010433/26/0104 | Cancelled | S4 | None |
| Hx-doxorubicin 10 mg/ 5 ML EACH 5,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/ 5 ml | 37003037/26/0030 | Registered | S4 | None |
| Hx-doxorubicin 50 mg/ 25 ML EACH 25,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/ 25 ML | 37003137/26/0031 | Registered | S4 | None |
| Cipla-doxorubicin 10 EACH 5,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10Injection | 41003441/26/0034 | Registered | S4 | PIPIL |
| Cipla-doxorubicin 50 EACH 25,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50Injection | 41003541/26/0035 | Registered | S4 | PIPIL |
| Doxolip EACH 1,0 ml SOLUTION CONTAINS: DOXORUBICIN HYDROCHLORIDE 2,0 mg | Not listed | 43001843/26/0018 | Registered | S4 | None |
| Doxorubicin accord 10 mg/5 ML EACH 1,0 ml SOLUTION CONTAINS :DOXORUBICIN HYDROCHLORIDE 2,0 mg | 10 mg/5 ml | 46048446/26/0484 | Registered | S4 | None |
| Doxorubicin accord 50 mg/25 ML EACH 1,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 2,0 mg | 50 mg/25 ml | 46048546/26/0485 | Registered | S4 | None |
| Rubexet 10 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/5 ml | 46048746/26/0487 | Registered | S4 | None |
| Rubexet 50 mg/25 ML EACH 25,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/25 ml | 46048846/26/0488 | Registered | S4 | None |
| Rubexet 200 mg/100 ML EACH 100,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 200,0 mg | 200 mg/100 ml | 46048946/26/0489 | Registered | S4 | None |
| Rubidoks 10 MG EACH VIAL CONTAINS: DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10 mg | 53007753/26/0077 | Registered | S4 | None |
| Rubidoks 20 MG EACH VIAL CONTAINS: DOXORUBICIN HYDROCHLORIDE 20, 0 mg | 20 mg | 53007853/26/0078 | Registered | S4 | None |
| Rubidoks 50 MG EACH VIAL CONTAINS: DOXORUBICIN HYDROCHLORIDE 50, 0 mg | 50 mg | 53007953/26/0079 | Registered | S4 | None |
| Rubidoks 100 MG EACH VIAL CONTAINS: DOXORUBICIN HYDROCHLORIDE 100,0 mg | 100 mg | 53008053/26/0080 | Registered | S4 | None |
| Rubidoks 200 MG EACH VIAL CONTAINS: DOXORUBICIN HYDROCHLORIDE 200,0 mg | 200 mg | 53008153/26/0081 | Registered | S4 | None |
| Doxred 10 lyophilized powder EACH VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10Powder | 57069857/26/0698 | Registered | S4 | None |
| Doxred 50 lyophilized powder EACH VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50Powder | 57069957/26/0699 | Registered | S4 | None |
| Doxorubicin "ebewe" 10 MG EACH 5,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 10,0 mg | 10 mg | A400352A40/26/0352 | Cancelled | S4 | None |
| Doxorubicin "ebewe" 50 MG EACH 25,0 ml SOLUTION CONTAINS DOXORUBICIN HYDROCHLORIDE 50,0 mg | 50 mg | A400353A40/26/0353 | Cancelled | S4 | None |
| Doxopeg EACH 1,0 ml SUSPENSION CONTAINS DOXORUBICIN HYDROCHLORIDE 2,0 mg | 2 mgLiposomal infusion. | A400389A40/26/0389Approved 7 August 2024 | Registered | S4 | PIPIL |
| Adriblastina rd 10 MG EACH VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 10 mg | 10 mg | F0274F/26/274 | Cancelled | S4 | None |
| Adriblastina rd 50 MG EACH VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 50 mg | 50 mg | F0289F/26/289 | Cancelled | S4 | None |
| Adriblastina rd 20 MG EACH VIAL CONTAINS DOXORUBICIN HYDROCHLORIDE 20 mg | 20 mg | U0183U/26/183 | Cancelled | S4 | None |
| Doxorubicin-sol pch 10 MG EACH 1 ml CONTAINS DOXORUBICIN HYDROCHLORIDE 2 mg | 10 mg | Z0167Z/26/167 | Registered | S4 | None |
| Doxorubicin-sol pch 50 MG EACH 1 ml CONTAINS DOXORUBICIN HYDROCHLORIDE 2 mg | 50 mg | Z0169Z/26/169 | Registered | S4 | None |
| Doxorubicin-sol pch 200 MG EACH 1 ml CONTAINS DOXORUBICIN HYDROCHLORIDE 2 mg | 200 mg | Z0170Z/26/170 | 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 Doxorubicin hydrochloride
S4: Doxorubicin
Consolidated Schedules 06 July 2026, line 6116
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.