Etanercept
Sold as Enbrel, Enbrel ps, Erelzi, Nepexto ps, Nepexto prefilled pen, Vencepa ps, Vencepa prefilled pen, Etreapext ps, Etreapext prefilled pen
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 4
- Registrations
- 14
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd | Enbrel | 25 mg | 340330 | S4 | None |
| Pfizer Laboratories Pfe (Pty) Ltd | Enbrel ps | 25 mg, 50 mg | 410762, 410763 | S4 | None |
| Sandoz South Africa (Pty) Ltd | Erelzi | 25 mg, 50 mg | 550392, 550393 | S4 | None |
| Imperial Market Access Healthcare SA (Pty) Ltd | Nepexto ps, Nepexto prefilled pen, Vencepa ps, Vencepa prefilled pen, Etreapext ps, Etreapext prefilled pen | 25, 50 | 550521, 550522, 550523, 550524.521, 550525.522, 550526.523, 550527.521, 550528.522, 550529.523 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Enbrel 25 MG EACH VIAL CONTAINS ETANERCEPT 25,0 mg | 25 mg | 34033034/3.1/0330 | Registered | S4 | None |
| Enbrel 25 MG ps EACH PRE-FILLED SYRINGE CONTAINS ETANERCEPT 25,0 mg | 25 mg | 41076241/3.1/0762 | Registered | S4 | None |
| Enbrel 50 MG ps EACH PRE-FILLED SYRINGE CONTAINS ETANERCEPT 50,0 mg | 50 mg | 41076341/3.1/0763 | Registered | S4 | None |
| Erelzi 25 MG EACH PRE-FILLED SYRINGE CONTAINS ETANERCEPT 25,0 mg | 25 mg | 55039255/3.1/0392 | Registered | S4 | None |
| Erelzi 50 MG EACH PRE-FILLED SYRINGE CONTAINS ETANERCEPT 50,0 mg | 50 mg | 55039355/3.1/0393 | Registered | S4 | None |
| Nepexto 25 ps EACH 0,5 ml SOLUTION CONTAINS ETANERCEPT 25,0 mg | 25 | 55052155/26/0521 | Registered | S4 | None |
| Nepexto 50 ps EACH 1,0 ml SOLUTION CONTAINS ETANERCEPT 50,0 mg | 50 | 55052255/26/0522 | Registered | S4 | None |
| Nepexto 50 prefilled pen EACH 1,0 ml SOLUTION CONTAINS ETANERCEPT 50,0 mg | 50 | 55052355/26/0523 | Registered | S4 | None |
| Vencepa 25 ps EACH 0,5 ml SOLUTION CONTAINS ETANERCEPT 25,0 mg | 25 | 550524.52155/26/0524.521 | Registered | S4 | None |
| Vencepa 50 ps EACH 1,0 ml SOLUTION CONTAINS ETANERCEPT 50,0 mg | 50 | 550525.52255/26/0525.522 | Registered | S4 | None |
| Vencepa 50 prefilled pen EACH 1,0 ml SOLUTION CONTAINS ETANERCEPT 50,0 mg | 50 | 550526.52355/26/0526.523 | Registered | S4 | None |
| Etreapext 25 ps EACH 0,5 ml SOLUTION CONTAINS ETANERCEPT 25,0 mg | 25 | 550527.52155/26/0527.521 | Registered | S4 | None |
| Etreapext 50 ps EACH 1,0 ml SOLUTION CONTAINS ETANERCEPT 50,0 mg | 50 | 550528.52255/26/0528.522 | Registered | S4 | None |
| Etreapext 50 prefilled pen EACH 1,0 ml SOLUTION CONTAINS ETANERCEPT 50,0 mg | 50 | 550529.52355/26/0529.523 | 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 Etanercept
S4: Etanercept
Consolidated Schedules 06 July 2026, line 6267
Pharmacological class: Antirheumatics (anti-inflammatory agents). (class 3.1)
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.