Quetiapine (Seroquel, Seroquel Xr, Truvalin, Truvalin Xr)
Quetiapine
Imperial Market Access Healthcare SA (Pty) Ltd
Registration
- Applicant
- Imperial Market Access Healthcare SA (Pty) Ltd
- Certificate holder
- Astrazeneca Pharmaceuticals (Pty) Ltd
- Registrations
- 18
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Seroquel 25 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 25,0 mg | 25Tablet | 32058932/2.6.5/0589Approved 8 January 2024 | Registered | S5 | PIPIL |
| Seroquel 100 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 100,0 mg | 100Tablet | 32059032/2.6.5/0590Approved 8 January 2024 | Registered | S5 | PIPIL |
| Seroquel 200 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 200,0 mg | 200Tablet | 32059132/2.6.5/0591Approved 8 January 2024 | Registered | S5 | PIPIL |
| Seroquel 300 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 300,0 mg | 300Tablet | 36007036/2.6.5/0070Approved 8 January 2024 | Registered | S5 | PIPIL |
| Seroquel xr 50 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 50,0 mg | 50Tablet | 42057342/2.6.5/0573Approved 3 June 2011 | Registered | S5 | PIPIL |
| Seroquel xr 200 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 200,0 mg | 200Tablet | 42057442/2.6.5/0574Approved 3 June 2011 | Registered | S5 | PIPIL |
| Seroquel xr 300 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 300,0 mg | 300Tablet | 42057542/2.6.5/0575Approved 3 June 2011 | Registered | S5 | PIPIL |
| Seroquel xr 400 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 400,0 mg | 400Tablet | 42057642/2.6.5/0576Approved 3 June 2011 | Registered | S5 | PIPIL |
| Truvalin 25 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 25,0 mg | 25 | 43015943/2.6.5/0159 | Registered | S5 | None |
| Truvalin 100 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 100,0 mg | 100 | 43016043/2.6.5/0160 | Registered | S5 | None |
| Truvalin 200 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 200,0 mg | 200 | 43016143/2.6.5/0161 | Registered | S5 | None |
| Truvalin 300 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 300,0 mg | 300 | 43016243/2.6.5/0162 | Registered | S5 | None |
| Seroquel xr 150 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 150,0 mg | 150Tablet | 44097344/2.6.5/0973Approved 3 June 2011 | Registered | S5 | PIPIL |
| Truvalin xr 150 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 150,0 mg | 150 | 44108544/2.6.5/1085 | Registered | S5 | None |
| Truvalin xr 50 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 50,0 mg | 50 | 45029345/2.6.5/0293 | Registered | S5 | None |
| Truvalin xr 200 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 200,0 mg | 200 | 45029445/2.6.5/0294 | Registered | S5 | None |
| Truvalin xr 300 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 300,0 mg | 300 | 45029545/2.6.5/0295 | Registered | S5 | None |
| Truvalin xr 400 EACH TABLET CONTAINS QUETIAPINE FUMARATE EQUIVALENT TO QUETIAPINE 400,0 mg | 400 | 45029645/2.6.5/0296 | 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, 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.