Paliperidone (Invega, Xeplion)
Paliperidone
Janssen Pharmaceutica (Pty) Ltd
Registration
- Applicant
- Janssen Pharmaceutica (Pty) Ltd
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Invega 3 MG EACH TABLET CONTAINS PALIPERIDONE 3,0 mg | 3 mg | 42028442/2.6.5/0284 | Registered | S5 | None |
| Invega 6 MG EACH TABLET CONTAINS PALIPERIDONE 6,0 mg | 6 mg | 42028542/2.6.5/0285 | Registered | S5 | None |
| Invega 9 MG EACH TABLET CONTAINS PALIPERIDONE 9,0 mg | 9 mg | 42028642/2.6.5/0286 | Cancelled | S5 | None |
| Invega 12 MG EACH TABLET CONTAINS PALIPERIDONE 12,0 mg | 12 mg | 42028742/2.6.5/0287 | Cancelled | S5 | None |
| Xeplion 25 mg/0,25 ML EACH PRE-FILLED SYRINGE CONTAINS PALIPERIDONE 25,0 mg | 25 mg/0,25 ml | 44086544/2.6.5/0865 | Registered | S5 | None |
| Xeplion 50 mg/0,50 ML EACH PRE-FILLED SYRINGE CONTAINS PALIPERIDONE 50,0 mg | 50 mg/0,50 ml | 44086644/2.6.5/0866 | Registered | S5 | None |
| Xeplion 75 mg/0,75 ML EACH PRE-FILLED SYRINGE CONTAINS PALIPERIDONE 75,0 mg | 75 mg/0,75 ml | 44086744/2.6.5/0867 | Registered | S5 | None |
| Xeplion 100 mg/1,0 ML EACH PRE-FILLED SYRINGE CONTAINS PALIPERIDONE 100,0 mg | 100 mg/1,0 ml | 44086844/2.6.5/0868 | Registered | S5 | None |
| Xeplion 150 mg/1,50 ML EACH PRE-FILLED SYRINGE CONTAINS PALIPERIDONE 150,0 mg | 150 mg/1,50 ml | 44087044/2.6.5/0870 | 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 Paliperidone
S5: Paliperidone
Consolidated Schedules 06 July 2026, line 9608
Pharmacological class: Miscellaneous structures. (class 2.6.5)
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.
3-[2-[4-(6-Fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one
Drag to rotate. Structure from PubChem CID 115237.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.