Naloxone
Sold as Naloxone HCL fresenius, Naloxone HCL neonatal fresenius, Pharma-q naloxone, Sabax naloxone
(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.
Background
Registration
- Applicants
- 3
- Registrations
- 4
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Fresenius Kabi Manufacturing SA (Pty) Ltd | Naloxone HCL fresenius, Naloxone HCL neonatal fresenius | 0,02 mg/1 ml, 0,4 mg/1 ml | 270157, 270158 | Not determined | None |
| Pharma-q Holdings (Pty) Ltd | Pharma-q naloxone | 0,4 mg/ml | 340165 | Not determined | None |
| Adcock Ingram Critical Care (Pty) Ltd | Sabax naloxone | 0,02 mg/ml | Z0003 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Naloxone HCL 0,4 mg/1 ML fresenius EACH 1,0 ml AMPOULE CONTAINS NALOXONE HYDROCHLORIDE 0,4 mg | 0,4 mg/1 ml | 27015727/1.4/0157 | Registered | Not determined | None |
| Naloxone HCL neonatal 0,02 mg/1 ML fresenius EACH 2 ml SOLUTION CONTAINS NALOXONE HYDROCHLORIDE 0,04 mg | 0,02 mg/1 ml | 27015827/1.4/0158 | Registered | Not determined | None |
| Pharma-q naloxone injection 0,4 mg/ml EACH 1,0 ml SOLUTION CONTAINS NALOXONE HYDROCHLORIDE 0,4 mg | 0,4 mg/mlInjection | 34016534/1.4/0165 | Registered | Not determined | None |
| 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
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Naloxone
Consolidated Schedules 06 July 2026, line 7206
2 of 2 approved products with this ingredient carry S6 on their leaflet.
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.