Erlotinib (Binit, Erlotinib Zydus)
Erlotinib
Zydus Healthcare (Pty) Ltd
Registration
- Applicant
- Zydus Healthcare (Pty) Ltd
- Certificate holder
- Zydus Healthcare SA (Pty) Ltd
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Binit 25 EACH TABLET CONTAINS ERLOTINIB HYDROCHLORIDE EQUIVALENT TO ERLOTINIB 25,0 mg | 25Tablets | 54082654/26/0826Approved 23 August 2022 | Registered | S4 | PIPIL |
| Binit 100 EACH TABLET CONTAINS ERLOTINIB HYDROCHLORIDE EQUIVALENT TO ERLOTINIB 100,0 mg | 100Tablets | 54082754/26/0827Approved 23 August 2022 | Registered | S4 | PIPIL |
| Binit 150 EACH TABLET CONTAINS ERLOTINIB HYDROCHLORIDE EQUIVALENT TO ERLOTINIB 150,0 mg | 150Tablets | 54082854/26/0828Approved 23 August 2022 | Registered | S4 | PIPIL |
| Erlotinib zydus 25 EACH TABLET CONTAINS ERLOTINIB HYDROCHLORIDE EQUIVALENT TO ERLOTINIB 25,0 mg | 25Tablets | 540829.82654/26/0829.826Approved 23 August 2022 | Registered | S4 | PIPIL |
| Erlotinib zydus 100 EACH TABLET CONTAINS ERLOTINIB HYDROCHLORIDE EQUIVALENT TO ERLOTINIB 100,0 mg | 100Tablets | 540830.82754/26/0830.827Approved 23 August 2022 | Registered | S4 | PIPIL |
| Erlotinib zydus 150 EACH TABLET CONTAINS ERLOTINIB HYDROCHLORIDE EQUIVALENT TO ERLOTINIB 150,0 mg | 150Tablets | 540831.82854/26/0831.828Approved 23 August 2022 | Registered | 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, 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 Erlotinib hydrochloride equivalent to erlotinib
S4: Erlotinib
Consolidated Schedules 06 July 2026, line 6233
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.
N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine
Drag to rotate. Structure from PubChem CID 176870.
SAHPRA documents
Schedule Verification
This medication's schedule (S4) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.