Rosuvastatin as rosuvastatin calcium (Rubistor)
Rosuvastatin as rosuvastatin calcium
Ruby Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Ruby Pharmaceuticals (Pty) Ltd
- Registrations
- 4
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Rubistor 10 MG EACH TABLET CONTAINS:ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10,0 mg | 10 mg | 54003654/3.1/0036 | Registered | Not determined | None |
| Rubistor 20 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 20,0 mg | 20 mg | 54003754/3.1/0037 | Registered | Not determined | None |
| Rubistor 40 MG EACH TABLET CONTAINS:ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 40,0 mg | 40 mg | 54003854/3.1/0038 | Registered | Not determined | None |
| Rubistor 5 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5,0 mg | 5 mg | 55047755/3.1/0477 | Registered | Not determined | None |
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: Calcium
- when indicated for the treatment of hyperphosphataemia; (S0)
- except in oral preparations or mixtures containing more than1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1)
- except in preparations thereof for injection; (S3)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 5618 to 5628
S4: Rosuvastatin
Consolidated Schedules 06 July 2026, line 7853
S3: Calcium
- in preparations thereof for injection; (S0)
- except in oral preparations or mixtures containing more than1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S1)
- except when indicated for the treatment of hyperphosphataemia; (S4)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 3262 to 3272
S1: Calcium
- in oral preparations or mixtures containing more than 1300 mg of calcium per recommended daily dose alone or in combination with other active pharmaceutical ingredients; (S0)
- except in preparations thereof for injection; (S3)
- except when indicated for the treatment of hyperphosphataemia; (S4)
- except when registered in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 302 to 312
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
SAHPRA has not published a professional information or patient information leaflet for this product.