Letrozole
Sold as Femara, Accord-letrozole, Laradex, Letoz, Letrozole adco, Femzole, Rozara, Zetra, Medpro letrozole, Cipla letrozole, Letraz, Rozilat, Fazalet, Lerotizar
4-[(4-Cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile
Drag to rotate. Structure from PubChem CID 3902.
Background
Registration
- Applicants
- 10
- Registrations
- 14
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) Ltd | Femara | 2,5 | 310378 | S4 | PIPIL |
| Accord Healthcare (Pty) Ltd | Accord-letrozole | 2,5 mg | 420323 | S4 | None |
| Eurolab (Pty) Ltd | Laradex | Not stated | 420324 | S4 | None |
| Zydus Healthcare (Pty) Ltd | Letoz | 2,5 | 430726 | S4 | None |
| Adcock Ingram Critical Care (Pty) Ltd1 of 2 cancelled | Letrozole adco, Femzole | 2,5 | 430733, 430734 | S4 | None |
| Ascendis Pharma (Pty) Ltd | Rozara | Not stated | 440154 | S4 | None |
| Pharmaplan (Pty) LtdCancelled | Zetra | Not stated | 440190 | S4 | None |
| Cipla Medpro (Pty) Ltd1 of 2 cancelled | Medpro letrozole, Cipla letrozole | 2,5 | 440281, 440282 | S4 | None |
| Equity Pharmaceutical (Pty) LtdCertificate held by Equity Pharmaceuticals (Pty) Ltd | Letraz | 2.5 mg | 450544 | S4 | PIPIL |
| Aurogen South Africa (Pty) LtdCertificate held by Aurogen SA (Pty) Ltd | Rozilat, Fazalet, Lerotizar | 2.5 mg | 550204, 550205.204, 550206.204 | S4 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Femara 2,5 EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5Film-coated tablets | 31037831/21.12/0378Approved 5 August 2025 | Registered | S4 | PIPIL |
| Accord-letrozole 2,5 MG EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5 mg | 42032342/21.12/0323 | Registered | S4 | None |
| Laradex EACH TABLET CONTAINS LETROZOLE 2,5 mg | Not listed | 42032442/21.12/0324 | Registered | S4 | None |
| Letoz 2,5 tablets EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5Tablets | 43072643/21.12/0726 | Registered | S4 | None |
| Letrozole adco 2,5 EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5 | 43073343/21.12/0733 | Cancelled | S4 | None |
| Femzole 2,5 EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5 | 43073443/21.12/0734 | Registered | S4 | None |
| Rozara EACH TABLET CONTAINS LETROZOLE 2,5 mg | Not listed | 44015444/21.12/0154 | Registered | S4 | None |
| Zetra EACH TABLET CONTAINS LETROZOLE 2,5 mg | Not listed | 44019044/21.12/0190 | Cancelled | S4 | None |
| Medpro letrozole 2,5 EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5 | 44028144/21.12/0281 | Cancelled | S4 | None |
| Cipla letrozole 2,5 EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2,5 | 44028244/21.12/0282 | Registered | S4 | None |
| Letraz EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2.5 mgFilm-coated tablet. | 45054445/21.12/0544Approved 6 May 2022 | Registered | S4 | PIPIL |
| Rozilat EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2.5 mgTablets | 55020455/21.12/0204Approved 29 June 2021 | Registered | S4 | PIPIL |
| Fazalet EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2.5 mgTablets | 550205.20455/21.12/0205.204Approved 29 June 2021 | Registered | S4 | PIPIL |
| Lerotizar EACH TABLET CONTAINS LETROZOLE 2,5 mg | 2.5 mgTablets | 550206.20455/21.12/0206.204Approved 29 June 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 Letrozole
S4: Letrozole
Consolidated Schedules 06 July 2026, line 6898
Pharmacological class: Hormone inhibitors. (class 21.12)
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
Femara 2,5, Novartis South Africa (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.