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Rosuvastatin (Rosuvakem)

Rosuvastatin

Ascend Laboratories (Pty) Ltd

Registration

Applicant
Ascend Laboratories (Pty) Ltd
Registrations
4

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Rosuvakem 5

EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5,0 mg

556086756/7.5/0867RegisteredNot determinedNone
Rosuvakem 10

EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10,0 mg

1056086856/7.5/0868RegisteredNot determinedNone
Rosuvakem 20

EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 20,0 mg

2056086956/7.5/0869RegisteredNot determinedNone
Rosuvakem 40

EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 40,0 mg

4056087056/7.5/0870RegisteredNot 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: Ezetimibe

    Consolidated Schedules 06 July 2026, line 6302

  • S4: Rosuvastatin

    Consolidated Schedules 06 July 2026, line 7853

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.

C22H28FN3O6S481.50 g/mol

(E,3R,5S)-7-[4-(4-Fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-propan-2-ylpyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid

Drag to rotate. Structure from PubChem CID 446157.

SAHPRA documents

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

Background

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Research articles

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