Alpelisib
Sold as Pivikto
(2S)-1-N-[4-Methyl-5-[2-(1,1,1-trifluoro-2-methylpropan-2-yl)-4-pyridinyl]-1,3-thiazol-2-yl]pyrrolidine-1,2-dicarboxamide
Drag to rotate. Structure from PubChem CID 56649450.
Background
Registration
- Applicants
- 1
- Registrations
- 3
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) Ltd | Pivikto | 50 mg, 150 mg, 200 mg | 550290, 550291, 550292 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pivikto 50 MG EACH TABLET CONTAINS ALPELISIB 50,0 mg | 50 mg | 55029055/26/0290 | Registered | S4 | None |
| Pivikto 150 MG EACH TABLET CONTAINS ALPELISIB 150,0 mg | 150 mg | 55029155/26/0291 | Registered | S4 | None |
| Pivikto 200 MG EACH TABLET CONTAINS ALPELISIB 200,0 mg | 200 mg | 55029255/26/0292 | 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 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 Alpelisib
S4: Alpelisib
Consolidated Schedules 06 July 2026, line 5198
Pharmacological class: Cytostatic agents (class 26)
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.