Quetiapine (Quetobex Xr, Noptiquel Xr)
Quetiapine
Abex Pharmaceutica (Pty) Ltd
Registration
- Applicant
- Abex Pharmaceutica (Pty) Ltd
- Certificate holder
- Abex Pharmaceutica (Pty) Ltd
- Registrations
- 10
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Quetobex xr 50 EACH TABLET CONTAINS :QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 50,O mg | 50Prolonged release tablets | 53031353/2.6.5/0313Approved 5 November 2024 | Registered | S5 | PIPIL |
| Quetobex xr 150 EACH TABLET CONTAINS: QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 150,0 mg | 150Prolonged release tablets | 53031453/2.6.5/0314Approved 5 November 2024 | Registered | S5 | PIPIL |
| Quetobex xr 200 EACH TABLET CONTAINS: QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 200,0 mg | 200Prolonged release tablets | 53031553/2.6.5/0315Approved 5 November 2024 | Registered | S5 | PIPIL |
| Quetobex xr 300 EACH TABLET CONTAINS: QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 300,0 mg | 300Prolonged release tablets | 53031653/2.6.5/0316Approved 5 November 2024 | Registered | S5 | PIPIL |
| Quetobex xr 400 EACH TABLET CONTAINS: QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 400,0 mg | 400Prolonged release tablets | 53031753/2.6.5/0317Approved 5 November 2024 | Registered | S5 | PIPIL |
| Noptiquel xr 50 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 50,O mg | 50Prolonged release tablets | 530318.31353/2.6.5/0318.313Approved 5 November 2024 | Registered | S5 | PIPIL |
| Noptiquel xr 150 EACH TABLET CONTAINS :QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 150,0 mg | 150Prolonged release tablets | 530319.31453/2.6.5/0319.314Approved 5 November 2024 | Registered | S5 | PIPIL |
| Noptiquel xr 200 EACH TABLET CONTAINS: QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 200,0 mg | 200Prolonged release tablets | 530320.31553/2.6.5/0320.015Approved 5 November 2024 | Registered | S5 | PIPIL |
| Noptiquel xr 300 EACH TABLET CONTAINS :QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 300,0 mg | 300Prolonged release tablets | 530321.31653/2.6.5/0321.316Approved 5 November 2024 | Registered | S5 | PIPIL |
| Noptiquel xr 400 EACH TABLET CONTAINS :QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 400,0 mg | 400Prolonged release tablets | 530322.31753/2.6.5/322.317Approved 5 November 2024 | Registered | S5 | PIPIL |
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, 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 Quetiapine fumarate equivalent to quetiapine
S5: Quetiapine
Consolidated Schedules 06 July 2026, line 9668
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.
2-[2-(4-Benzo[b][1,4]benzothiazepin-6-ylpiperazin-1-yl)ethoxy]ethanol
Drag to rotate. Structure from PubChem CID 5002.
SAHPRA documents
Schedule Verification
This medication's schedule (S5) 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.