Isotretinoin
Sold as Acnetane, Oratane, Acnetret, Supatane, Roaccutane
(2Z,4E,6E,8E)-3,7-Dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
Drag to rotate. Structure from PubChem CID 5282379.
Background
Registration
- Applicants
- 5
- Registrations
- 12
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limited | Acnetane | 10 mg, 20 mg | 340356, 340357 | S5 | None |
| Acino Pharma (Pty) Ltd | Oratane | 5 mg, 10 mg, 20 mg, 40 mg | 350375, 350376, 420460, 430746 | S5 | None |
| Cipla Medpro (Pty) Ltd | Acnetret | 10, 20 | 380265, 380267 | S5 | None |
| Austell Pharmaceuticals (Pty) Ltd | Supatane | 8 mg, 16 mg | 510006, 510007 | S5 | None |
| Equity Pharmaceutical (Pty) Ltd | Roaccutane | 10 mg, 20 mg | R0118, R0119 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Acnetane 10 MG EACH CAPSULE CONTAINS ISOTRETINOIN 10,0 mg | 10 mg | 34035634/13.4.2/0356 | Registered | S5 | None |
| Acnetane 20 MG EACH CAPSULE CONTAINS ISOTRETINOIN 20,0 mg | 20 mg | 34035734/13.4.2/0357 | Registered | S5 | None |
| Oratane 10 MG EACH CAPSULE CONTAINS: ISOTRETINOIN 10,0 mg | 10 mg | 35037535/13.4.2/0375 | Registered | S5 | None |
| Oratane 20 MG EACH CAPSULE CONTAINS :ISOTRETINOIN 20,0 mg | 20 mg | 35037635/13.4.2/0376 | Registered | S5 | None |
| Acnetret 20 EACH CAPSULE CONTAINS ISOTRETINOIN 20,0 mg | 20 | 38026538/13.4.2/0265 | Registered | S5 | None |
| Acnetret 10 EACH CAPSULE CONTAINS ISOTRETINOIN 10,0 mg | 10 | 38026738/13.4.2/0267 | Registered | S5 | None |
| Oratane 40 MG EACH CAPSULE CONTAINS: ISOTRETINOIN 40,0 mg | 40 mg | 42046042/13.4.2/0460 | Registered | S5 | None |
| Oratane 5 MG EACH CAPSULE CONTAINS: ISOTRETINOIN 5,0 mg | 5 mg | 43074643/13.4.2/0746 | Registered | S5 | None |
| Supatane 8 MG Each capsule contains ISOTRETINOIN 8,0 mg | 8 mg | 51000651/13.4.2/0006 | Registered | S5 | None |
| Supatane 16 MG Each capsule contains ISOTRETINOIN 16,0 mg | 16 mg | 51000751/13.4.2/0007 | Registered | S5 | None |
| Roaccutane 10 MG EACH CAPSULE CONTAINS ISOTRETINOIN 10 mg | 10 mg | R0118R/13.4.2/118 | Registered | S5 | None |
| Roaccutane 20 MG capsules EACH CAPSULE CONTAINS ISOTRETINOIN 20 mg | 20 mgCapsules | R0119R/13.4.2/119 | Registered | S5 | None |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, 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.
Consolidated Schedules listings for Isotretinoin
S5: Isotretinoin
Consolidated Schedules 06 July 2026, line 9501
Pharmacological class: Emollients and protectives. (class 13.4.2)
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.