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zameds

Atorvastatin, ezetimibe

Sold as Dytorez, Dynator plus

Loading the molecular structure
C33H35FN2O5558.60 g/mol

(3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoic acid

Drag to rotate. Structure from PubChem CID 60823.

Background

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Registration

Applicants
1
Registrations
5

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Pharma Dynamics (Pty) Ltd3 of 5 cancelledDytorez, Dynator plus10/10, 10/20, 10/80, 10/10 mg, 10/20 mg540326, 540327, 540329, 540330.326, 540331.327Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Dytorez 10/10

EACH TABLET CONTAINS EZETIMIBE 10,0 mg, ATORVASTATIN CALCIUM TRIHYDRATE EQUIVALENT TO ATORVASTATIN 10,0 mg

10/1054032654/7.5/0326CancelledNot determinedNone
Dytorez 10/20

EACH TABLET CONTAINS EZETIMIBE 10,0 mg, ATORVASTATIN CALCIUM TRIHYDRATE 20,0 mg

10/2054032754/7.5/0327CancelledNot determinedNone
Dytorez 10/80

EACH TABLET CONTAINS EZETIMIBE 10,0 mg, ATORVASTATIN CALCIUM TRIHYDRATE 80,0 mg

10/8054032954/7.5/0329CancelledNot determinedNone
Dynator plus 10/10 MG

EACH TABLET CONTAINS EZETIMIBE 10,0 mg, ATORVASTATIN CALCIUM TRIHYDRATE 10,0 mg

10/10 mg540330.32654/7.5/0330RegisteredNot determinedNone
Dynator plus 10/20 MG

EACH TABLET CONTAINS EZETIMIBE 10,0 mg, ATORVASTATIN CALCIUM TRIHYDRATE 20,0 mg

10/20 mg540331.32754/7.5/0331RegisteredNot determinedNone

Regulatory status

This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.

Listings for this ingredient that could not be applied to this product

  • S4: Atorvastatin

    Consolidated Schedules 06 July 2026, line 5376

  • S4: Ezetimibe

    Consolidated Schedules 06 July 2026, line 6302

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

SAHPRA has not published a professional information or patient information leaflet for this product.

Research articles

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