Ezetimibe, simvastatin (Inegy)
Ezetimibe, simvastatin
Organon South Africa (Pty) Ltd
Registration
- Applicant
- Organon South Africa (Pty) Ltd
- Certificate holder
- Organon South Africa (Pty) Ltd
- Registrations
- 4
- Schedule source
- Consolidated Schedules 06 July 2026
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Inegy 10/10 EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 10,0 mg | 10/10Tablet | A390031A39/7.5/0031Approved 28 May 2024 | Registered | S4 | PIPIL |
| Inegy 10/20 EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg | 10/20Tablet | A390032A39/7.5/0032Approved 28 May 2024 | Registered | S4 | PIPIL |
| Inegy 10/40 EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg | 10/40Tablet | A390033A39/7.5/0033Approved 28 May 2024 | Registered | S4 | PIPIL |
| Inegy 10/80 EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 80,0 mg | 10/80Tablet | A390034A39/7.5/0034Approved 28 May 2024 | Registered | S4 | PIPIL |
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 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 Ezetimibe, simvastatin
S4: Ezetimibe
Consolidated Schedules 06 July 2026, line 6302
S4: Simvastatin
Consolidated Schedules 06 July 2026, line 7936
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.