Rosuvastatin (Rosuvastatin Unicorn, Rovalip, Tactduo)
Rosuvastatin
Sandoz South Africa (Pty) Ltd
Registration
- Applicant
- Sandoz South Africa (Pty) Ltd
- Certificate holder
- Sandoz SA (Pty) Ltd1
- Registrations
- 12
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Rosuvastatin unicorn 5 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5,0 mg | 5mg/10mg/20mg/40mgFilm-coated tablets | 46030746/7.5/0307Approved 12 May 2022 | Registered | S4 | PIPIL |
| Rosuvastatin unicorn 10 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10,0 mg | 5mg/10mg/20mg/40mgFilm-coated tablets | 46030846/7.5/0308Approved 12 May 2022 | Registered | S4 | PIPIL |
| Rosuvastatin unicorn 20 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 20,0 mg | 5mg/10mg/20mg/40mgFilm-coated tablets | 46030946/7.5/0309Approved 12 May 2022 | Registered | S4 | PIPIL |
| Rosuvastatin unicorn 40 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 40,0 mg | 5mg/10mg/20mg/40mgFilm-coated tablets | 46031046/7.5/0310Approved 12 May 2022 | Registered | S4 | PIPIL |
| Rovalip 5 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5,0 mg | 5 | 46089346/7.5/0893 | Registered | Not determined | None |
| Rovalip 10 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10,0 mg | 10 | 46089446/7.5/0894 | Registered | Not determined | None |
| Rovalip 20 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 20,0 mg | 20 | 46089546/7.5/0895 | Registered | Not determined | None |
| Rovalip 40 EACH TABLET CONTAINS ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 40,0 mg | 40 | 46089646/7.5/0896 | 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 |
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 Rosuvastatin calcium equivalent to rosuvastatin
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)
Matched through the component Ezetimibe.
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.
(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
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.