Pantoprazole (Topraflux Iv, Topraflux, Pantoprazole Unicorn, Topraflux Otc, Pantoprazole Otc Unicorn)
Pantoprazole
Sandoz South Africa (Pty) Ltd
Registration
- Applicant
- Sandoz South Africa (Pty) Ltd
- Registrations
- 7
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Topraflux iv EACH VIAL CONTAINS PANTOPRAZOLE SODIUM EQUIVALENT TO PANTOPRAZOLE 40,0 mg | Not listed | 41034541/11.4.3/0345 | Cancelled | Not determined | None |
| Topraflux 20 EACH TABLET CONTAINS PANTOPRAZOLE 20,0 mg | 20 | 43048343/11.4.3/0483 | Registered | Not determined | None |
| Topraflux 40 EACH TABLET CONTAINS PANTOPRAZOLE 40,0 mg | 40 | 43048443/11.4.3/0484 | Registered | Not determined | None |
| Pantoprazole unicorn 20 EACH TABLET CONTAINS PANTOPRAZOLE 20,0 mg | 20mg/40mgTablets | 43048543/11.4.3/0485Approved 13 December 2021 | Registered | S4 | PIPIL |
| Pantoprazole unicorn 40 EACH TABLET CONTAINS PANTOPRAZOLE 40,0 mg | 20mg/40mgTablets | 43048643/11.4.3/0486Approved 13 December 2021 | Registered | S4 | PIPIL |
| Topraflux otc Each tablet contains PANTOPRAZOLE SODIUM SESQUIHYDRATE EQUIVALENT TO PANTOPRAZOLE 20,0 mg | Not listed | 52014252/11.4.3/0142 | Registered | Not determined | None |
| Pantoprazole otc unicorn Each tablet contains PANTOPRAZOLE SODIUM SESQUIHYDRATE EQUIVALENT TO PANTOPRAZOLE 20,0 mg | Not listed | 52014352/11.4.3/0143 | Registered | Not determined | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, 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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Pantoprazole
S4: Pantoprazole
- except when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:
- a maximum daily dose of 20 milligrams (S2); and
- a maximum treatment period of 14 days. (S2)
Consolidated Schedules 06 July 2026, lines 7479 to 7482
S2: Pantoprazole
- when intended for the temporary short-term relief of heartburn and hyperacidity, subject to:
- maximum daily dose of 20 milligrams
- maximum treatment period of 14 days. (S4)
Consolidated Schedules 06 July 2026, lines 2482 to 2486
Pharmacological class: Other. (class 11.4.3)
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.
6-(Difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole
Drag to rotate. Structure from PubChem CID 4679.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) 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.