Methotrexate
Sold as Methotrexate-faulding, P & u methotrexate csv, P&u methotrexate csv, Abitrexate, Methotrexate fresenius, Mexate, Methotrexate accord, Methotrexate lederle, Emthexate
(2S)-2-[[4-[(2,4-Diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]pentanedioic acid
Drag to rotate. Structure from PubChem CID 126941.
Background
Registration
- Applicants
- 6
- Registrations
- 14
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd4 of 5 cancelled | Methotrexate-faulding, P & u methotrexate csv, P&u methotrexate csv, Methotrexate lederle | 2,5 mg, 25 mg/ml, 50 mg/2 ml, 500 mg/20 ml, 1000 mg/10 ml | 290363, 290502, 300311, 340226, H2766 | S4 | PIPIL |
| Teva Pharmaceuticals (Pty) Ltd | Abitrexate | 1 g, 2,5 mg, 5g, 50, 500 | 370466, T0057, T0063, T0064, W0386 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Methotrexate fresenius | 50 mg/ 2ml | 490814 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Mexate | Not stated | 540019 | S4 | None |
| Accord Healthcare (Pty) Ltd | Methotrexate accord | 2,5 mg | 540879 | S4 | None |
| Pharmachemie (Pty) LtdCancelled | Emthexate | 50 mg | S0346 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Methotrexate-faulding 25 mg/ml EACH 1 ml CONTAINS METHOTREXATE 25 mg | 25 mg/ml | 29036329/26/0363 | Cancelled | S4 | None |
| P & u methotrexate csv 500 mg/20 ML injection EACH 1 ml CONTAINS METHOTREXATE 25 mg | 500 mg/20 mlInjection | 29050229/26/0502 | Cancelled | S4 | None |
| P & u methotrexate csv 50 mg/2 ML injection EACH 1 ml SOLUTION CONTAINS METHOTREXATE 25 mg | 50 mg/2 mlInjection | 30031130/26/0311 | Cancelled | S4 | None |
| P&u methotrexate csv 1000 mg/10 ML injection EACH 1,0 ml SOLUTION CONTAINS METHOTREXATE 100,0 mg | 1000 mg/10 mlInjection | 34022634/26/0226 | Cancelled | S4 | None |
| Abitrexate 2,5 MG EACH TABLET CONTAINS METHOTREXATE 2,5 mg | 2,5 mg | 37046637/26/0466 | Registered | S4 | None |
| Methotrexate 50 mg/ 2ml fresenius EACH 2 ml CONCENTRATE CONTAINS: METHOTREXATE 50,0 mg | 50 mg/ 2ml | 49081449/26/0814 | Registered | S4 | None |
| Mexate EACH TABLET CONTAINS METHOTREXATE DISODIUM EQUIVALENT TO METHOTREXATE 2,5 mg | Not listed | 54001954/26/0019 | Registered | S4 | None |
| Methotrexate 2,5 MG tablets accord EACH TABLET CONTAINS METHOTREXATE DISODIUM EQUIVALENT TO METHOTREXATE 2,5 mg | 2,5 mgTablets | 54087954/26/0879 | Registered | S4 | None |
| Methotrexate lederle 2,5 EACH TABLET CONTAINS METHOTREXATE A 2,5 mg | 2,5 mgTablets | H2766Approved 28 September 2022 | Old Medicine | S4 | PIPIL |
| Emthexate 50 MG EACH 1 ml SOLUTION CONTAINS METHOTREXATE 25 mg | 50 mg | S0346S/26/346 | Cancelled | S4 | None |
| Abitrexate 1 g EACH 10 ml SOLUTION CONTAINS METHOTREXATE 1,0 g | 1 g | T0057T/26/57 | Registered | S4 | None |
| Abitrexate 50 EACH 2 ml INJECTION CONTAINS METHOTREXATE 50 mg | 50 | T0063T/26/63 | Registered | S4 | None |
| Abitrexate 500 EACH 1 ml INJECTION CONTAINS METHOTREXATE 25 mg | 500 | T0064T/26/64 | Registered | S4 | None |
| Abitrexate 5g EACH VIAL CONTAINS METHOTREXATE 5 g | 5g | W0386W/26/386 | 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 Methotrexate
S4: Methotrexate
Consolidated Schedules 06 July 2026, line 7090
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
Schedule Verification
Methotrexate lederle 2,5, Pfizer Laboratories (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.