Methotrexate (Methotrexate-faulding, P & U Methotrexate Csv, P&u Methotrexate Csv, Methotrexate Lederle)
Methotrexate
Pfizer Laboratories (Pty) Ltd
Registration
- Applicant
- Pfizer Laboratories (Pty) Ltd
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
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 |
| Methotrexate lederle 2,5 EACH TABLET CONTAINS METHOTREXATE A 2,5 mg | 2,5 mgTablets | H2766Approved 28 September 2022 | Old Medicine | S4 | PIPIL |
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.
(2S)-2-[[4-[(2,4-Diaminopteridin-6-yl)methyl-methylamino]benzoyl]amino]pentanedioic acid
Drag to rotate. Structure from PubChem CID 126941.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.