Buprenorphine (Subutex Sublingual, Sobrixa, Temgesic, Temgesic Sublingual)
Buprenorphine
Adcock Ingram Critical Care (Pty) Ltd
Registration
- Applicant
- Adcock Ingram Critical Care (Pty) Ltd
- Registrations
- 8
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Subutex sublingual 0,4 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,4 mg | 0,4 mg | 33037733/34/0377 | Cancelled | S6 | None |
| Subutex sublingual 2,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 2,0 mg | 2,0 mg | 33037833/34/0378 | Cancelled | S6 | None |
| Subutex sublingual 8,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg | 8,0 mg | 33037933/34/0379 | Cancelled | S6 | None |
| Sobrixa 0,4 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,4 mg | 0,4 mg | 60035160/34/0351 | Registered | S6 | None |
| Sobrixa 2,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 2,0 mg | 2,0 mg | 600352600/34/0352 | Registered | S6 | None |
| Sobrixa 8,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg | 8,0 mg | 60035360/34/0353 | Registered | S6 | None |
| Temgesic 1 ML EACH 1,0 ml SOLUTION CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,3 mg | 1 ml | L0157L/2.9/157 | Registered | S6 | None |
| Temgesic sublingual tablets EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,2 mg | Tablets | S0327S/2.7/327 | Registered | S6 | None |
Regulatory status
Where S6 sits on the scale
Prescription-only, no repeats without a new prescription.
Schedule 6 covers the most tightly controlled ordinary prescription medicines. Every dispensing needs its own new prescription; nothing can be repeated on the same script. When prescribed, the quantity must be written out in both figures and words. 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 S6, 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 Buprenorphine hydrochloride equivalent to buprenorphine
S6: Buprenorphine
Consolidated Schedules 06 July 2026, line 10099
Pharmacological class: Complementary Medicines: Health Supplements (class 34)
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.
(1S,2S,6R,14R,15R,16R)-5-(Cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol
Drag to rotate. Structure from PubChem CID 644073.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.