Ezetimibe, rosuvastatin
Sold as Rozumib, Lypstaplus, Tactduo, Suvemib, Ristomib
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 4
- Registrations
- 18
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Teva Pharmaceuticals (Pty) LtdCancelled | Rozumib | 5/10, 10/10, 20/10, 40/10 | 55/7.5/0411, 550409, 550410, 550412 | S4 | None |
| Abbott Laboratories S.A. (Pty) Ltd | Lypstaplus | 10 mg/10 mg, 20 mg/10 mg | 550779, 550780 | Not determined | None |
| Sandoz South Africa (Pty) Ltd | Tactduo | 10/5, 10/10, 10/20, 10/40 | 561081, 561082, 561083, 561084 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Suvemib, Ristomib | 5/10 mg, 10/10 mg, 20/10 mg, 40/10 mg | 570561, 570562, 570563, 570564, 570565.561, 570566.562, 570567.563, 570568.564 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Rozumib 20/10 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 20,0 mg & EZETIMIBE 10,0 mg | 20/10 | 55/7.5/0411 | Cancelled | S4 | None |
| Rozumib 5/10 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5,0 mg & EZETIMIBE 10,0 mg | 5/10 | 55040955/7.5/0409 | Cancelled | S4 | None |
| Rozumib 10/10 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10,0 mg & EZETIMIBE 10,0 mg | 10/10 | 55041055/7.5/0410 | Cancelled | S4 | None |
| Rozumib 40/10 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 40,0 mg & EZETIMIBE 10,0 mg | 40/10 | 55041255/7.5/0412 | Cancelled | S4 | None |
| Lypstaplus 10 mg/10 MG EACH TABLET CONTAINS ROSUVASTATIN CALCIUM 10,0 mg EZETIMIBE 10,0 mg | 10 mg/10 mg | 55077955/7.5/0779 | Registered | Not determined | None |
| Lypstaplus 20 mg/10 MG EACH TABLET CONTAINS ROSUVASTATIN CALCIUM 20,0 mg EZETIMIBE 10,0 mg | 20 mg/10 mg | 55078055/7.5/0780 | Registered | Not determined | None |
| Tactduo 10/5 EACH TABLET CONTAINS EZETIMIBE 10,0 mg ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5,0 mg | 10/5 | 56108156/7.5/1081 | Registered | Not determined | None |
| Tactduo 10/10 EACH TABLET CONTAINS EZETIMIBE 10,0 mg ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10,0 mg | 10/10 | 56108256/7.5/1082 | Registered | Not determined | None |
| Tactduo 10/20 EACH TABLET CONTAINS EZETIMIBE 10,0 mg ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 20,0 mg | 10/20 | 56108356/7.5/1083 | Registered | Not determined | None |
| Tactduo 10/40 EACH TABLET CONTAINS EZETIMIBE 10,0 mg ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 40,0 mg | 10/40 | 56108456/7.5/1084 | Registered | Not determined | None |
| Suvemib 5/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 5,0 mg EZETIMIBE 10,0 mg | 5/10 mg | 57056157/7.5/0561 | Registered | S4 | None |
| Suvemib 10/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 10,0 mg EZETIMIBE 10,0 mg | 10/10 mg | 57056257/7.5/0562 | Registered | S4 | None |
| Suvemib 20/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 20,0 mg EZETIMIBE 10,0 mg | 20/10 mg | 57056357/7.5/0563 | Registered | S4 | None |
| Suvemib 40/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 40,0 mg EZETIMIBE 10,0 mg | 40/10 mg | 57056457/7.5/0564 | Registered | S4 | None |
| Ristomib 5/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 5,0 mg EZETIMIBE 10,0 mg | 5/10 mg | 570565.56157/7.5/0565.561 | Registered | S4 | None |
| Ristomib 10/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 10,0 mg EZETIMIBE 10,0 mg | 10/10 mg | 570566.56257/7.5/0566.562 | Registered | S4 | None |
| Ristomib 20/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 20,0 mg EZETIMIBE 10,0 mg | 20/10 mg | 570567.56357/7.5/0567.563 | Registered | S4 | None |
| Ristomib 40/10 MG EACH TABLET CONTAINS: ROSUVASTATIN CALCIUM EQUIVALENT TO: ROSUVASTATIN 40,0 mg EZETIMIBE 10,0 mg | 40/10 mg | 570568.56457/7.5/0568.564 | Registered | S4 | None |
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 Rosuvastatin calcium equivalent to rosuvastatin, & ezetimibe
S4: Ezetimibe
Consolidated Schedules 06 July 2026, line 6302
S4: Rosuvastatin
Consolidated Schedules 06 July 2026, line 7853
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
SAHPRA has not published a professional information or patient information leaflet for this product.