Palbociclib
Sold as Palbociclib cipla, Ibrance, Palbociclib pfizer, Palvored
6-Acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-yl-2-pyridinyl)amino]pyrido[2,3-d]pyrimidin-7-one
Drag to rotate. Structure from PubChem CID 5330286.
Background
Registration
- Applicants
- 4
- Registrations
- 12
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cipla Medpro (Pty) Ltd | Palbociclib cipla | 75 mg, 100 mg, 125 mg | 560161, 560162, 560163 | S4 | PIPIL |
| Pfizer Laboratories Pfe (Pty) Ltd | Ibrance | 75 mg | 561064 | S4 | None |
| Pfizer Laboratories (Pty) Ltd | Ibrance, Palbociclib pfizer | 75 mg, 100 mg, 125 mg | 561065, 561066, 561067.1064, 561068.1065, 561069.1066 | S4 | None |
| Dr Reddyæs Laboratories (Pty) Ltd | Palvored | 75, 100, 125 | 570520, 570521, 570522 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Palbociclib 75 MG cipla PALBOCICLIB | 75 mgCapsule | 56016156/26/0161Approved 28 February 2023 | Registered | S4 | PIPIL |
| Palbociclib 100 MG cipla PALBOCICLIB | 100 mgCapsule | 56016256/26/0162Approved 28 February 2023 | Registered | S4 | PIPIL |
| Palbociclib 125 MG cipla PALBOCICLIB | 125 mgCapsule | 56016356/26/0163Approved 28 February 2023 | Registered | S4 | PIPIL |
| Ibrance tablets 75 MG EACH TABLET CONTAINS PALBOCICLIB 75,0 mg | 75 mgTablets | 56106456/26/1064 | Registered | S4 | None |
| Ibrance tablets 100 MG EACH TABLET CONTAINS PALBOCICLIB 100,0 mg | 100 mgTablets | 56106556/26/1065 | Registered | S4 | None |
| Ibrance tablets 125 MG EACH TABLET CONTAINS PALBOCICLIB 125,0 mg | 125 mgTablets | 56106656/26/1066 | Registered | S4 | None |
| Palbociclib 75 MG tablets pfizer EACH TABLET CONTAINS PALBOCICLIB 75,0 mg | 75 mgTablets | 561067.106456/26/1067.1064 | Registered | S4 | None |
| Palbociclib 100 MG tablets pfizer EACH TABLET CONTAINS PALBOCICLIB 100,0 mg | 100 mgTablets | 561068.106556/26/1068.1065 | Registered | S4 | None |
| Palbociclib 125 MG tablets pfizer EACH TABLET CONTAINS PALBOCICLIB 125,0 mg | 125 mgTablets | 561069.106656/26/1069.1066 | Registered | S4 | None |
| Palvored 75 EACH CAPSULE CONTAINS: PALBOCICLIB 75,0 mg | 75 | 57052057/26/0520 | Registered | S4 | None |
| Palvored 100 EACH CAPSULE CONTAINS: PALBOCICLIB 100,0 mg | 100 | 57052157/26/0521 | Registered | S4 | None |
| Palvored 125 EACH CAPSULE CONTAINS: PALBOCICLIB 125,0 mg | 125 | 57052257/26/0522 | 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 Palbociclib
S4: Palbociclib
Consolidated Schedules 06 July 2026, line 7457
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
Palbociclib 75 MG cipla, Cipla Medpro (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.