Gefitinib
Sold as Iressa, Gefirix
N-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholin-4-ylpropoxy)quinazolin-4-amine
Drag to rotate. Structure from PubChem CID 123631.
Background
Registration
- Applicants
- 2
- Registrations
- 2
- Schedule source
- SAHPRA documentation
Applicants and registrations
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Iressa 250 MG EACH TABLET CONTAINS: GEFITINIB 250,0 mg | 250 mgFilm-coated tablets | 54049054/26/0490Approved 24 March 2022 | Registered | S4 | PIPIL |
| Gefirix EACH TABLET CONTAINS GEFITINIB 250,0 mg | 250mgTablet | 55011555/26/0115Approved 26 October 2021 | 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 Gefitinib
S4: Gefitinib
Consolidated Schedules 06 July 2026, line 6509
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
Iressa 250 MG, 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.