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zameds

Ezetimibe, simvastatin

Sold as Inechol, Tryzetor plus, Simezyd, Sezutil, Ezimva, Ezetimibe simvastatin alkem, Ducetim plus, Inegy

S4Read from the PI-PIL document and verified

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Background

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Registration

Applicants
6
Registrations
25
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Biotech Laboratories (Pty) LtdCertificate held by Biotech Laboratories (Pty) Ltd.Inechol10/10, 10/20, 10/40480444, 480445, 480446S4PIPIL
Pharma Dynamics (Pty) LtdTryzetor plus10/10, 10/20, 10/40511007, 511008, 511009S4PIPIL
Zydus Healthcare (Pty) LtdSimezyd, Sezutil10/20, 10/40540015, 540016, 540017, 540018.016S4None
Ascend Laboratories (Pty) LtdEzimva, Ezetimibe simvastatin alkem10/10, 10/20, 10/40, 10/80, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mg540137, 540138, 540139, 540140, 540141.137, 540142.138, 540143.139, 540144.14S4None
Pharmacare limited û woodmeadCertificate held by Pharmacare limitedDucetim plus10/10, 10/20, 10/40540690, 540691, 540692S4PIPIL
Organon South Africa (Pty) LtdInegy10/10, 10/20, 10/40, 10/80A390031, A390032, A390033, A390034S4PIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Inechol 10/10

EACH TABLET CONTAINS: EZETIMIBE 10,0 mg SIMVASTATIN 10,0 mg

10/10Tablets48044448/7.5/0444Approved 16 March 2026RegisteredS4PIPIL
Inechol 10/20

EACH TABLET CONTAINS: EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg

10/20Tablets48044548/7.5/0445Approved 16 March 2026RegisteredS4PIPIL
Inechol 10/40

EACH TABLET CONTAINS: EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg

10/40Tablets48044648/7.5/0446Approved 16 March 2026RegisteredS4PIPIL
Tryzetor plus 10/1010/10Tablets.51100751/7.5/1007Approved 29 January 2025RegisteredS4PIPIL
Tryzetor plus 10/2010/20Tablets.51100851/7.5/1008Approved 29 January 2025RegisteredS4PIPIL
Tryzetor plus 10/4010/40Tablets.51100951/7.5/1009Approved 29 January 2025RegisteredS4PIPIL
Simezyd 10/20

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg

10/2054001554/7.5/0015RegisteredS4None
Simezyd 10/40

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg

10/4054001654/7.5/0016RegisteredS4None
Sezutil 10/20

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg

10/2054001754/7.5/0017.015RegisteredS4None
Sezutil 10/40

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg

10/40540018.01654/7.5/0018.016RegisteredS4None
Ezimva 10/10

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 10,0 mg

10/1054013754/7.5/0137RegisteredS4None
Ezimva 10/20

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg

10/2054013854/7.5/0138RegisteredS4None
Ezimva 10/40

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg

10/4054013954/7.5/0139RegisteredS4None
Ezimva 10/80

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 80,0 mg

10/8054014054/7.5/0140RegisteredS4None
Ezetimibe simvastatin alkem 10 mg/10 MG

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 10,0 mg

10 mg/10 mg540141.13754/7.5/0141.137RegisteredS4None
Ezetimibe simvastatin alkem 10 mg/20 MG

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg

10 mg/20 mg540142.13854/7.5/0142.138RegisteredS4None
Ezetimibe simvastatin alkem 10 mg/40 MG

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg

10 mg/40 mg540143.13954/7.5/0143.139RegisteredS4None
Ezetimibe simvastatin alkem 10 mg/80 MG

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 80,0 mg

10 mg/80 mg540144.1454/7.5/0144.140RegisteredS4None
Ducetim plus 10/10

EACH TABLET CONTAINS EZETIMIBE 10,0 mgSIMVASTATIN 10,0 mg

10/10Tablets54069054/7.5/0690Approved 30 August 2022RegisteredS4PIPIL
Ducetim plus 10/20

EACH TABLET CONTAINS EZETIMIBE 10,0 mgSIMVASTATIN 20,0 mg

10/20Tablets54069154/7.5/0691Approved 30 August 2022RegisteredS4PIPIL
Ducetim plus 10/40

EACH TABLET CONTAINS EZETIMIBE 10,0 mgSIMVASTATIN 40,0 mg

10/40Tablets54069254/7.5/0692Approved 30 August 2022RegisteredS4PIPIL
Inegy 10/10

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 10,0 mg

10/10TabletA390031A39/7.5/0031Approved 28 May 2024RegisteredS4PIPIL
Inegy 10/20

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 20,0 mg

10/20TabletA390032A39/7.5/0032Approved 28 May 2024RegisteredS4PIPIL
Inegy 10/40

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 40,0 mg

10/40TabletA390033A39/7.5/0033Approved 28 May 2024RegisteredS4PIPIL
Inegy 10/80

EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 80,0 mg

10/80TabletA390034A39/7.5/0034Approved 28 May 2024RegisteredS4PIPIL

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 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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Inechol 10/10, Biotech Laboratories (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsInechol 10/10, Biotech Laboratories (Pty) LtdPatient information leaflet (PIL)For patients and carersInechol 10/10, Biotech Laboratories (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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