Terbinafine (Terbane Nail, Terbinafine Unicorn, Terbane, Terbaspor Topical)
Terbinafine
Sandoz South Africa (Pty) Ltd
Registration
- Applicant
- Sandoz South Africa (Pty) Ltd
- Certificate holder
- Sandoz SA (Pty) Ltd
- Registrations
- 4
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Terbane nail EACH 1,0 ml SOLUTION CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 78,22 mg | 10 % w/wMedicated nail lacquer | 56109256/20.2.2/1092Approved 22 October 2024 | Registered | S1 | PIPIL |
| Terbinafine unicorn 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | A380395A38/20.2.2/0395 | Registered | Not determined | None |
| Terbane 10 MG EACH 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | 10 mg | A390009A39/20.2.2/0009 | Registered | Not determined | None |
| Terbaspor topical cream EACH 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | Cream | A390010A39/20.2.2/0010 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Terbinafine hydrochloride equivalent to terbinafine
S4: Terbinafine
- except when intended for application to the skin.
Consolidated Schedules 06 July 2026, line 8132
S1: Terbinafine
- when intended for application to the skin.
Consolidated Schedules 06 July 2026, line 1094
Pharmacological class: Fungicides. (class 20.2.2)
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.
(E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine
Drag to rotate. Structure from PubChem CID 1549008.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) 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.