Ezetimibe
Sold as Ezetrol, Ducetim, Ezotak, Etrolta, Zetichol, Hetmibe, Hetezit, Timhet, Ezorb, Mibezit, Toleze, Ezetimibe adco, Novabe, Makzetib
(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one
Drag to rotate. Structure from PubChem CID 150311.
Background
Registration
- Applicants
- 8
- Registrations
- 14
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Organon South Africa (Pty) Ltd | Ezetrol | 10 mg | 370413 | S4 | None |
| Pharmacare limited û woodmead | Ducetim | 10 | 470038 | S4 | None |
| Aurogen South Africa (Pty) LtdCancelled | Ezotak, Etrolta, Zetichol | Not stated | 520279, 520280.279, 520281.279 | S4 | None |
| Hetero Drugs South Africa (Pty) Ltd | Hetmibe, Hetezit, Timhet | 10 | 530395.593, 530593, 530594.593 | S4 | None |
| Austell Pharmaceuticals (Pty) LtdCertificate held by Austell Pharmaceuticals (Pty) Ltd | Ezorb, Mibezit | 10,0 mg | 540364, 540365.364 | S4 | PIPIL |
| Adcock ingram limited | Toleze, Ezetimibe adco | 10 | 540617, 540618.617 | S4 | None |
| Novagen Pharma (Pty) LtdCancelled | Novabe | 10 mg | 550381 | S4 | PIPIL |
| Macleods Pharmaceuticals SA (Pty) Ltd | Makzetib | 10 mg | 561038 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ezetrol 10 MG EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10 mg | 37041337/7.5/0413 | Registered | S4 | None |
| Ducetim 10 EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10 | 47003847/7.5/0038 | Registered | S4 | None |
| Ezotak EACH TABLET CONTAINS: EZETIMIBE 10,0 mg | Not listed | 52027952/7.5/0279 | Cancelled | S4 | None |
| Etrolta EACH TABLET CONTAINS: EZETIMIBE 10,0 mg | Not listed | 520280.27952/7.5/0280.279 | Cancelled | S4 | None |
| Zetichol EACH TABLET CONTAINS: EZETIMIBE 10,0 mg | Not listed | 520281.27952/7.5/0281.279 | Cancelled | S4 | None |
| Hetmibe 10 EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10 | 530395.59353/7.5/0595.593 | Registered | S4 | None |
| Hetezit 10 EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10 | 53059353/7.5/0593 | Registered | S4 | None |
| Timhet 10 EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10 | 530594.59353/7.5/0594.593 | Registered | S4 | None |
| Ezorb EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10,0 mgTablet | 54036454/7.5/0364Approved 13 September 2022 | Registered | S4 | PIPIL |
| Mibezit EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10,0 mgTablet | 540365.36454/7.5/0365.364Approved 13 September 2022 | Registered | S4 | PIPIL |
| Toleze 10 EACH TABLET CONTAINS: EZETIMIBE 10,0 mg | 10 | 54061754/7.5/0617 | Registered | S4 | None |
| Ezetimibe 10 adco EACH TABLET CONTAINS: EZETIMIBE 10,0 mg | 10 | 540618.61754/7.5/0617.618 | Registered | S4 | None |
| Novabe EACH TABLET CONTAINS: EZETIMIBE 10,0 mg | 10 mgTablets | 55038155/7.5/0381Approved 6 April 2022 | Cancelled | S4 | PIPIL |
| Makzetib 10 MG EACH TABLET CONTAINS EZETIMIBE 10,0 mg | 10 mg | 56103856/7.5/1038 | Registered | S4 | 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, 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; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Ezetimibe
S4: Ezetimibe
Consolidated Schedules 06 July 2026, line 6302
Pharmacological class: Serum-cholesterol reducers. (class 7.5)
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
Ezorb, Austell Pharmaceuticals (Pty) Ltd is scheduled S4 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.