Fentanyl (Sublimaze)
Fentanyl
Piramal Critical Care South Africa (Pty) Ltd
Registration
- Applicant
- Piramal Critical Care South Africa (Pty) Ltd
- Certificate holder
- Piramal Critical Care South Africa (Pty) Ltd
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Sublimaze 2 ML 1 ML FENTANYL CITRATE 0,0785 MG | 2ml/10 mlInjection | B1014B/2.9/1014Approved 24 July 2025 | Registered | S6 | PIPIL |
| Sublimaze 10 ML EACH 1 ml CONTAINS FENTANYL CITRATE 0,0785 Mg EQUIVALENT TO 0,05MG FENTANYL BASE | 2ml/10 mlInjection | Q0034Q/2.9/0034Approved 24 July 2025 | Registered | S6 | PIPIL |
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.
The Consolidated Schedules list this ingredient up to S7; the leaflet's S6 applies to this product.
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 Fentanyl citrate
S6: Fentanyl
- when intended for therapeutic purposes.
Consolidated Schedules 06 July 2026, line 10256
Pharmacological class: Other analgesics. (class 2.9)
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.
N-Phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]propanamide
Drag to rotate. Structure from PubChem CID 3345.
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.