Pravastatin
Sold as Aspen pravastatin, Colite, Pixeta, Pravastatin unimed, Austell pravastatin, Ran-pravastatin, Gulf pravastatin, Novales
(3R,5R)-7-[(1S,2S,6S,8S,8AR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid
Drag to rotate. Structure from PubChem CID 54687.
Background
Registration
- Applicants
- 8
- Registrations
- 21
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead | Aspen pravastatin | 10 mg, 20 mg, 40 mg | 380123, 380139, 380140 | S4 | None |
| Zydus Healthcare (Pty) LtdCancelled | Colite | 10, 20, 40, 80 | 410409, 410410, 410411, 410412 | S4 | None |
| Accord Healthcare (Pty) Ltd | Pixeta | 10, 20, 40 | 420358, 420372, 420373 | S4 | None |
| Unimed Healthcare (Pty) Ltd | Pravastatin unimed | 10, 20, 40 | A390300, A390301, A390302 | S4 | None |
| Austell Pharmaceuticals (Pty) LtdCancelled | Austell pravastatin | 10 mg, 20 mg, 40 mg | A400093, A400094, A400095 | S4 | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Ran-pravastatin | 10, 20, 40 | A400474, A400475, A400476 | S4 | None |
| Gulf Drug Company (Pty) LtdCancelled | Gulf pravastatin | 20 | A400711 | S4 | None |
| Activo Health (Pty) LtdCancelled | Novales | 20 | A400749 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Aspen pravastatin 10 MG EACH TABLET CONTAINS PRAVASTATIN SODIUM 10,0 mg | 10 mg | 38012338/7.5/0123 | Registered | S4 | None |
| Aspen pravastatin 20 MG EACH TABLET CONTAINS PRAVASTATIN SODIUM 20,0 mg | 20 mg | 38013938/7.5/0139 | Registered | S4 | None |
| Aspen pravastatin 40 MG EACH TABLET CONTAINS PRAVASTATIN SODIUM 40,0 mg | 40 mg | 38014038/7.5/0140 | Registered | S4 | None |
| Colite 10 EACH TABLET CONTAINS PRAVASTATIN SODIUM 10,0 mg | 10 | 41040941/7.5/0409 | Cancelled | S4 | None |
| Colite 20 EACH TABLET CONTAINS PRAVASTATIN SODIUM 20,0 mg | 20 | 41041041/7.5/0410 | Cancelled | S4 | None |
| Colite 40 EACH TABLET CONTAINS PRAVASTATIN SODIUM 40,0 mg | 40 | 41041141/7.5/0411 | Cancelled | S4 | None |
| Colite 80 EACH TABLET CONTAINS PRAVASTATIN SODIUM 80,0 mg | 80 | 41041241/7.5/0412 | Cancelled | S4 | None |
| Pixeta 40 EACH TABLET CONTAINS: PRAVASTATIN SODIUM 40,0 mg | 40 | 42035842/7.5/0358 | Registered | S4 | None |
| Pixeta 10 EACH TABLET CONTAINS PRAVASTATIN SODIUM 10,0 mg | 10 | 42037242/7.5/0372 | Registered | S4 | None |
| Pixeta 20 EACH TABLET CONTAINS: PRAVASTATIN SODIUM 20,0 mg | 20 | 42037342/7.5/0373 | Registered | S4 | None |
| Pravastatin 10 unimed EACH TABLET CONTAINS PRAVASTATIN SODIUM 10,0 mg | 10 | A390300A39/7.5/0300 | Registered | S4 | None |
| Pravastatin 20 unimed EACH TABLET CONTAINS PRAVASTATIN SODIUM 20,0 mg | 20 | A390301A39/7.5/0301 | Registered | S4 | None |
| Pravastatin 40 unimed EACH TABLET CONTAINS PRAVASTATIN SODIUM 40,0 mg | 40 | A390302A39/7.5/0302 | Registered | S4 | None |
| Austell pravastatin 10 MG EACH TABLET CONTAINS PRAVASTATIN SODIUM 10,0 mg | 10 mg | A400093A40/7.5/0093 | Cancelled | S4 | None |
| Austell pravastatin 20 MG EACH TABLET CONTAINS PRAVASTATIN SODIUM 20,0 mg | 20 mg | A400094A40/7.5/0094 | Cancelled | S4 | None |
| Austell pravastatin 40 MG EACH TABLET CONTAINS PRAVASTATIN SODIUM 40,0 mg | 40 mg | A400095A40/7.5/0095 | Cancelled | S4 | None |
| Ran-pravastatin 10 EACH TABLET CONTAINS: PRAVASTATIN SODIUM 10,0 mg | 10 | A400474A40/7.5/0474 | Registered | S4 | None |
| Ran-pravastatin 20 EACH TABLET CONTAINS: PRAVASTATIN SODIUM 20,0 mg | 20 | A400475A40/7.5/0475 | Registered | S4 | None |
| Ran-pravastatin 40 EACH TABLET CONTAINS: PRAVASTATIN SODIUM 40,0 mg | 40 | A400476A40/7.5/0476 | Registered | S4 | None |
| Gulf pravastatin 20 EACH TABLET CONTAINS PRAVASTATIN SODIUM 20,0 mg | 20 | A400711A40/7.5/0711 | Cancelled | S4 | None |
| Novales 20 EACH TABLET CONTAINS PRAVASTATIN SODIUM 20,0 mg | 20 | A400749A40/7.5/0749 | Cancelled | 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 high.
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 Pravastatin sodium
S4: Pravastatin
Consolidated Schedules 06 July 2026, line 7630
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.