Epirubicin
Sold as Farmorubicin csv, Epirubicin hcl-hexal, Epirubicin-hexal, Hx-epirubicin, Cipla-epirubicin, Aspen epirubicin, Epicord, Accord epirubicin, Merck epirubicin, Epirubicin fresenius, Farmorubicin rd
(7S,9S)-7-[(2R,4S,5R,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 41867.
Background
Registration
- Applicants
- 9
- Registrations
- 29
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd2 of 4 cancelled | Farmorubicin csv, Farmorubicin rd | 10 mg/5 ml, 10, 50 mg/25 ml, 50 | 320600, 320602, Y0397, Y0398 | S4 | None |
| Sandoz South Africa (Pty) LtdCancelled | Epirubicin hcl-hexal, Epirubicin-hexal | 10 mg/5 ML, 50 mg/25 ML | 370125, 370126 | S4 | None |
| Hexal Pharma (SA) (Pty) LtdCancelled | Epirubicin-hexal | 100 mg/50 ML, 200 mg/100 ML | 370127, 370128 | S4 | None |
| Oethmaan Biosims (Pty) Ltd | Hx-epirubicin | 10 mg/5 ML, 50 mg/25 ML, 100 mg/50 ML, 200 mg/100 ML | 370387, 370388, 370389, 370390 | S4 | None |
| Cipla Medpro (Pty) LtdCancelled | Cipla-epirubicin | 10, 50 | 410979, 410980 | S4 | None |
| Pharmacare limited û woodmeadCancelled | Aspen epirubicin | 10 mg, 10 mg/5 ml, 20 mg/10 ml, 50 mg, 50 mg/25 ml, 100 mg/50 ml, 200 mg/100 ml | 420018, 420019, 420528, 420529, 420530, 420531, 420532 | S4 | None |
| Accord Healthcare (Pty) Ltd | Epicord, Accord epirubicin | 10, 50 | 420152, 420153, 420897 | S4 | None |
| Viatris South Africa (Pty) Ltd | Merck epirubicin | 10 mg, 50 mg | 420744, 420745 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Epirubicin fresenius | 10 mg/5 ml, 50 mg/25 ml, 200 mg/100 ml | 450617, 450618, 450619 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Farmorubicin csv 10 mg/5 ML EACH 5,0 ml VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/5 ml | 32060032/26/0600 | Cancelled | S4 | None |
| Farmorubicin csv 50 mg/25 ML EACH 25,0 ml VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/25 ml | 32060232/26/0602 | Cancelled | S4 | None |
| Epirubicin hcl-hexal 10 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/5 ML | 37012537/26/0125 | Cancelled | S4 | None |
| Epirubicin-hexal 50 mg/25 ML EACH 25,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/25 ML | 37012637/26/0126 | Cancelled | S4 | None |
| Epirubicin-hexal 100 mg/50 ML EACH 50,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 100,0 mg | 100 mg/50 ML | 37012737/26/0127 | Cancelled | S4 | None |
| Epirubicin-hexal 200 mg/100 ML EACH 100,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 200,0 mg | 200 mg/100 ML | 37012837/26/0128 | Cancelled | S4 | None |
| Hx-epirubicin 10 mg/5 ML EACH 1,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 2,0 mg | 10 mg/5 ML | 37038737/26/0387 | Registered | S4 | None |
| Hx-epirubicin 50 mg/25 ML EACH 1,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 2,0 mg | 50 mg/25 ML | 37038837/26/0388 | Registered | S4 | None |
| Hx-epirubicin 100 mg/50 ML EACH 1,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 2,0 mg | 100 mg/50 ML | 37038937/26/0389 | Registered | S4 | None |
| Hx-epirubicin 200 mg/100 ML EACH 1,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 2,0 mg | 200 mg/100 ML | 37039037/26/0390 | Registered | S4 | None |
| Cipla-epirubicin 10 EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 | 41097941/26/0979 | Cancelled | S4 | None |
| Cipla-epirubicin 50 EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE EQUIVALENT TO EPIRUBICIN 50,0 mg | 50 | 41098041/26/0980 | Cancelled | S4 | None |
| Aspen epirubicin 10 MG EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 mg | 42001842/26/0018 | Cancelled | S4 | None |
| Aspen epirubicin 50 MG EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 mg | 42001942/26/0019 | Cancelled | S4 | None |
| Epicord 10 EACH 1,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 2,0 mg | 10 | 42015242/26/0152 | Registered | S4 | None |
| Accord epirubicin 10 EACH 1,0 ml SOLUTION CONTAINS :EPIRUBICIN HYDROCHLORIDE 2,0 mg | 10 | 42015342/26/0153 | Registered | S4 | None |
| Aspen epirubicin 10 mg/5 ML EACH 5,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/5 ml | 42052842/26/0528 | Cancelled | S4 | None |
| Aspen epirubicin 20 mg/10 ML EACH 10,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 20,0 mg | 20 mg/10 ml | 42052942/26/0529 | Cancelled | S4 | None |
| Aspen epirubicin 50 mg/25 ML EACH 25,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/25 ml | 42053042/26/0530 | Cancelled | S4 | None |
| Aspen epirubicin 100 mg/50 ML EACH 50,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 100,0 mg | 100 mg/50 ml | 42053142/26/0531 | Cancelled | S4 | None |
| Aspen epirubicin 200 mg/100 ML EACH 100,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 200,0 mg | 200 mg/100 ml | 42053242/26/0532 | Cancelled | S4 | None |
| Merck epirubicin 10 MG EACH 5,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 mg | 42074442/26/0744 | Registered | S4 | None |
| Merck epirubicin 50 MG EACH 25,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 mg | 42074542/26/0745 | Registered | S4 | None |
| Epicord 50 EACH 1,0 ml SOLUTION CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 | 42089742/26/0897 | Registered | S4 | None |
| Epirubicin 10 mg/5 ML fresenius EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 10,0 mg | 10 mg/5 ml | 45061745/26/0617 | Registered | S4 | None |
| Epirubicin 50 mg/25 ML fresenius EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 50,0 mg | 50 mg/25 ml | 45061845/26/0618 | Registered | S4 | None |
| Epirubicin 200 mg/100 ML fresenius EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 200,0 mg | 200 mg/100 ml | 45061945/26/0619 | Registered | S4 | None |
| Farmorubicin rd 10 EACH VIALCONTAINS EPIRUBICIN HYDROCHLORIDE 10 mg | 10 | Y0397Y/26/397 | Registered | S4 | None |
| Farmorubicin rd 50 EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 50 mg | 50 | Y0398Y/26/398 | 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 Epirubicin hydrochloride
S4: Epirubicin
Consolidated Schedules 06 July 2026, line 6207
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
SAHPRA has not published a professional information or patient information leaflet for this product.