Haloperidol
Sold as Haloperidol GDC, Haloject, Haloperidol cipla, Haloperidol medpro, Haloperidol ascendis, Amperi, Serenace, Tamide, Haloperidol oethmaan
4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one
Drag to rotate. Structure from PubChem CID 3559.
Background
Registration
- Applicants
- 8
- Registrations
- 12
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gulf Drug Company (Pty) Ltd | Haloperidol GDC | 5 | 420065 | S5 | None |
| Viatris Healthcare (Pty) LtdCancelled | Haloject | 5 mg/ml | 420075 | S5 | None |
| Cipla Medpro (Pty) LtdCancelled | Haloperidol cipla, Haloperidol medpro | Not stated | 470559, 470561 | S5 | None |
| Ascendis Pharma (Pty) LtdCancelled | Haloperidol ascendis | 5 mg/ml | 490212 | S5 | None |
| Unimed Healthcare (Pty) LtdCertificate held by Lebasi Pharmaceuticals (Pty) Ltd | Amperi | 5 mg | 560059 | S5 | PIPIL |
| Pharmacia South Africa (Pty) LtdCertificate held by PfizerCancelled | Serenace | 1,5 | B1563 | S5 | PI |
| Pharmacare limited û woodmeadCancelled | Tamide | 1, 1,5, 5 | K0094, K0113, L0167 | S5 | None |
| Oethmaan Biosims (Pty) Ltd | Haloperidol oethmaan | 1,5, 5 | Q0169, Q0170 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Haloperidol 5 GDC EACH TABLET CONTAINS HALOPERIDOL 5,0 mg | 5 | 42006542/2.6.5/0065 | Registered | S5 | None |
| Haloject 5 mg/ml EACH 1,0 ml SOLUTION CONTAINS HALOPERIDOL 5,0 mg | 5 mg/ml | 42007542/2.6.5/0075 | Cancelled | S5 | None |
| Haloperidol cipla EACH 1,0 ml SOLUTION CONTAINS HALOPERIDOL 5,0 mg | Not listed | 47055947/2.6.5/0559 | Cancelled | S5 | None |
| Haloperidol medpro EACH 1,0 ml SOLUTION CONTAINS HALOPERIDOL 5,0 mg | Not listed | 47056147/2.6.5/0561 | Cancelled | S5 | None |
| Haloperidol 5 mg/ml ascendis EACH 1 ML AMPOULE CONTAINS HALOPERIDOL 5,0 mg | 5 mg/ml | 49021249/2.6.5/0212 | Cancelled | S5 | None |
| Amperi 5 mg/ml EACH 1,0 ml SOLUTION CONTAINS HALOPERIDOL 5,0 mg | 5 mgSolution for injection | 56005956/2.6.5/0059Approved 18 April 2023 | Registered | S5 | PIPIL |
| Serenace 1,5 EACH TABLET CONTAINS HALOPERIDOL A 1,5 mg | 1,5Injection | B1563Approved 17 February 2006 | Cancelled | S5 | PI |
| Tamide - 1 EACH TABLET CONTAINS HALOPERIDOL 1 mg | - 1 | K0094K/2.6.5/94 | Cancelled | S5 | None |
| Tamide - 1,5 EACH TABLET CONTAINS HALOPERIDOL 1,5 mg | - 1,5 | K0113K/2.6.5/113 | Cancelled | S5 | None |
| Tamide - 5 EACH TABLET CONTAINS HALOPERIDOL 5 mg | - 5 | L0167L/2.6.5/167 | Cancelled | S5 | None |
| Haloperidol 1,5 oethmaan EACH TABLET CONTAINS HALOPERIDOL 1,5 mg | 1,5 | Q0169Q/2.6.5/169 | Registered | S5 | None |
| Haloperidol 5 oethmaan EACH TABLET CONTAINS HALOPERIDOL 5 mg | 5 | Q0170Q/2.6.5/170 | 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 Haloperidol
S5: Haloperidol
Consolidated Schedules 06 July 2026, line 9463
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.
SAHPRA documents
Schedule Verification
Amperi 5 mg/ml, Unimed Healthcare (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.