Naloxone (Suboxone, Narbup, Sabax Naloxone)
Naloxone
Adcock Ingram Critical Care (Pty) Ltd
Registration
- Applicant
- Adcock Ingram Critical Care (Pty) Ltd
- Registrations
- 5
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Suboxone 2 MG EACH SUBLINGUAL TABLET CONTAINS: BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 2,0 mg, NALOXONE HYDROCHLORIDE EQUIVALENT TO NALOXONE 0,5 mg | 2 mg | 41101041/34/1010 | Cancelled | Not determined | None |
| Suboxone 8 MG EACH SUBLINGUAL TABLET CONTAINS :BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg, NALOXONE HYDROCHLORIDE EQUIVALENT TO NALOXONE 2,0 mg | 8 mg | 41101141/34/1011 | Cancelled | Not determined | None |
| Narbup 2 MG EACH TABLET CONTAINS: BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 2,0 mg ,NALOXONE HYDROCHLORIDE EQUIVALENT TO NALOXONE 0,5 mg | 2 mgSublingual tablet | 60034960/32.16/0349Approved 27 January 2026 | Registered | S6 | PIPIL |
| Narbup 8 MG EACH TABLET CONTAINS: BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg ,NALOXONE HYDROCHLORIDE EQUIVALENT TO NALOXONE 2,0 mg | 8 mgSublingual tablet | 60035060/32.16/0350Approved 27 January 2026 | Registered | S6 | PIPIL |
| Sabax naloxone 0,02 mg/ml EACH 1 ml SOLUTION CONTAINS NALOXONE HYDROCHLORIDE 0,02 mg | 0,02 mg/ml | Z0003Z/1.4/3 | Registered | Not determined | 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, read from the product's PI-PIL leaflet.
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, naloxone hydrochloride equivalent to naloxone
S6: Buprenorphine
Consolidated Schedules 06 July 2026, line 10099
S6: Oxycodone
Consolidated Schedules 06 July 2026, line 10363
S4: Naloxone
Consolidated Schedules 06 July 2026, line 7206
Pharmacological class: Others. (class 32.16)
Matched through the components Buprenorphine, Oxycodone.
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.
(4R,4AS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one
Drag to rotate. Structure from PubChem CID 5284596.
SAHPRA documents
Schedule Verification
This medication's schedule (S6) 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.