Adalimumab
Sold as Humira, Amgevita, Adalimumab fresenius, Rumio, Hydimoz
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 5
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Abbvie (Pty) Ltd | Humira | 20 mg/0,2 ml, 40 mg/0,4 ml, 80 mg/0,8 ml | 501042, 530061, 530062 | S4 | None |
| Amgen south africa (pty)ltd | Amgevita | 20 mg, 40 mg | 510677, 510678 | S4 | None |
| Fresenius Kabi South Africa (Pty) Ltd | Adalimumab fresenius | 40 mg/0,8 ml | 550285 | S4 | None |
| Cipla Medpro (Pty) Ltd | Rumio | 40, 80 | 560361, 560362 | S4 | None |
| Sandoz South Africa (Pty) Ltd | Hydimoz | 40 mg 8 ml /, | 560665 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Humira 40 mg/0,4 ML EACH 0,4 ml SOLUTION CONTAINS: ADALIMUMAB 40,0 mg | 40 mg/0,4 ml | 50104250/30.1/1042 | Registered | S4 | None |
| Amgevita 20 MG EACH 0,4 ml CONTAINS: ADALIMUMAB 20,0 mg | 20 mg | 51067751/30.1/0677 | Registered | S4 | None |
| Amgevita 40 MG EACH 0,8 ml CONTAINS: ADALIMUMAB 40,0 mg | 40 mg | 51067851/30.1/0678 | Registered | S4 | None |
| Humira 20 mg/0,2 ML EACH 0,2 ml SOLUTION CONTAINS: ADALIMUMAB 20,0 mg | 20 mg/0,2 ml | 53006153/30.1/0061 | Registered | S4 | None |
| Humira 80 mg/0,8 ML EACH 0,8 ml SOLUTION CONTAINS: ADALIMUMAB 80,0 mg | 80 mg/0,8 ml | 53006253/30.1/0062 | Registered | S4 | None |
| Adalimumab 40 mg/0,8 ML fresenius EACH 0,8 ml SOLUTION CONTAINS ADALIMUMAB 40,0 mg | 40 mg/0,8 ml | 55028555/30.2/0285 | Registered | S4 | None |
| Rumio 40 EACH PRE_FILLED SYRINGE CONTAINS ADALIMUMAB 40,0 mg | 40 | 56036156/36.1/0361 | Registered | S4 | None |
| Rumio 80 EACH PRE_FILLED SYRINGE CONTAINS ADALIMUMAB 80,0 mg | 80 | 56036256/30.1/0362 | Registered | S4 | None |
| Hydimoz 40 mg/,8 ML EACH 0,8 ml SOLUTION CONTAINS ADALIMUMAB 40,0 mg | 40 mg 8 ml /, | 56066556/30.1/0665 | 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 Adalimumab
S4: Adalimumab
Consolidated Schedules 06 July 2026, line 5144
Pharmacological class: Antibodies. (class 30.1)
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.