Betahistine (Bistochira)
Betahistine
Evohealth (Pty) Ltd
Registration
- Applicant
- Evohealth (Pty) Ltd
- Registrations
- 3
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bistochira 8 EACH TABLET CONTAINS: BETAHISTINE DIHYDROCHLORIDE 8,0 mg | 8 | 57080457/5.6/0804 | Registered | S3 | None |
| Bistochira 16 EACH TABLET CONTAINS: BETAHISTINE DIHYDROCHLORIDE 16,0 mg | 16 | 57080557/5.6/0805 | Registered | S3 | None |
| Bistochira 24 EACH TABLET CONTAINS: BETAHISTINE DIHYDROCHLORIDE 24,0 mg | 24 | 57080657/5.6/0806 | Registered | S3 | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, matched to the Consolidated Schedules by ingredient, confidence medium.
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 Betahistine dihydrochloride
S3: Betahistine
Consolidated Schedules 06 July 2026, line 3211
Pharmacological class: Histamine. (class 5.6)
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.
No structure available
This product's active ingredient could not be matched to a single known compound.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.