Ibrutinib
Sold as Imbruvica
1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
Drag to rotate. Structure from PubChem CID 24821094.
Background
Registration
- Applicants
- 1
- Registrations
- 5
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Imbruvica 140 MG EACH CAPSULE CONTAINS IBRUTINIB 140,0 mg | 140 mg | 50093950/26/0939 | Cancelled | S4 | None |
| Imbruvica 140 EACH TABLET CONTAINS IBRUTINIB 140,0 mg | 140Film-coated tablets | 55029755/26/0297Approved 11 June 2025 | Registered | S4 | PIPIL |
| Imbruvica 280 EACH TABLET CONTAINS IBRUTINIB 280,0 mg | 280Film-coated tablets | 55029855/26/0298Approved 11 June 2025 | Cancelled | S4 | PIPIL |
| Imbruvica 420 EACH TABLET CONTAINS IBRUTINIB 420,0 mg | 420Film-coated tablets | 55029955/26/0299Approved 11 June 2025 | Registered | S4 | PIPIL |
| Imbruvica 560 EACH TABLET CONTAINS IBRUTINIB 560,0 mg | 560Film-coated tablets | 55030055/26/0300Approved 11 June 2025 | Cancelled | S4 | PIPIL |
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 Ibrutinib
S4: Ibrutinib
Consolidated Schedules 06 July 2026, line 6706
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.