Acalabrutinib
Sold as Calquence, Acalabrutinib cipla, Gencalq
4-[8-Amino-3-[(2S)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-pyridin-2-ylbenzamide
Drag to rotate. Structure from PubChem CID 71226662.
Background
Registration
- Applicants
- 2
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Calquence EACH CAPSULE CONTAINS ACALABRUTINIB 100,0 mg | 100mgCapsule | 55039055/26/0390Approved 23 September 2025 | Registered | S4 | PIPIL |
| Acalabrutinib cipla EACH CAPSULE CONTAINS ACALABRUTINIB 100,0 mg | 100 mgCapsule | 57003357/26/0033Approved 4 July 2023 | Registered | S4 | PIPIL |
| Gencalq EACH CAPSULE CONTAINS ACALABRUTINIB 100,0 mg | 100 mgCapsule | 570034.03357/26/0034.033Approved 4 July 2023 | Registered | S4 | PIPIL |
| Calquence tablets EACH TABLET CONTAINS: ACALABRUTINIB MALEATE EQUVALENT TO ACALABRUTINIB 100,0 mg | Tablets | 57049457/26/0494 | 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, 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 Acalabrutinib
S4: Acalabrutinib
Consolidated Schedules 06 July 2026, line 5133
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
Schedule Verification
Calquence, Astrazeneca Pharmaceuticals (Pty) Ltd is scheduled S4 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.