Terbinafine
Sold as Lamisil, Lamisil dermgel, Terbicil, Adco terbinafine, AURO terbinafine, Almatil, Lamibane, Binacil, Adco-lamiderm, Terbane nail, Terbinafine unicorn, Terbane, Terbinafine viatris, Arrow terbinafine hci, Terbaspor topical, Nafin, Lamifem, Lamisil film forming, Lamispor, Cipla-terbinafine
(E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine
Drag to rotate. Structure from PubChem CID 1549008.
Background
Registration
- Applicants
- 13
- Registrations
- 27
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock ingram limitedCertificate held by Novartis south africa2 of 5 cancelled | Lamisil, Adco terbinafine, Adco-lamiderm | 1 %, 1%, 250 | 310613, 411114, 420129, 420572, Z0186 | S4 | PIPIL |
| Glaxosmithkline Consumer Healthcare SA (Pty) Ltd | Lamisil dermgel, Lamifem, Lamisil film forming | 1 %, solution | 320564, A390309, A390439 | Not determined | None |
| Pharmacare limited û woodmead | Terbicil | 1% | 380148, A380484 | Not determined | None |
| Novagen Pharma (Pty) LtdCancelled | AURO terbinafine | 125 mg, 250 mg | 420271, 420272 | Not determined | None |
| Acino Pharma (Pty) Ltd | Almatil | 1 % | 420382 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Lamibane, Nafin | 250 | 420446, A390118 | Not determined | None |
| Aurogen South Africa (Pty) Ltd | Binacil | 125 mg, 250 mg | 420471, 420472 | Not determined | None |
| Sandoz South Africa (Pty) LtdCertificate held by Sandoz SA (Pty) Ltd | Terbane nail, Terbinafine unicorn, Terbane, Terbaspor topical | 10 % w/w, 10 mg, 250, cream | 561092, A380395, A390009, A390010 | S1 | PIPIL |
| Hexal Pharma (SA) (Pty) Ltd | Terbane | 250 | A380397 | Not determined | None |
| Viatris South Africa (Pty) Ltd | Terbinafine viatris | 250 mg | A380691 | Not determined | None |
| Astral Pharma (Pty) Ltd | Arrow terbinafine hci | 250 | A380697 | Not determined | None |
| Cipla Medpro (Pty) Ltd1 of 2 cancelled | Lamispor, Cipla-terbinafine | 250 | A400614, A400615 | Not determined | None |
| Novartis South Africa (Pty) Ltd | Lamisil | 250 mg | Z0185 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Lamisil 1 % spray EACH 1 g SPRAY SOLUTION CONTAINS TERBINAFINE 10,0 mg | 1 %Spray | 31061331/20.2.2/0613 | Registered | Not determined | None |
| Lamisil dermgel EACH 1,0 g GEL CONTAINS TERBINAFINE 10,0 mg | Not listed | 32056432/20.2.2/0564 | Registered | Not determined | None |
| Terbicil 1% cream EACH 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | 1%Cream | 38014838/20.2.2/0148 | Registered | Not determined | None |
| Adco terbinafine 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | 41111441/20.2.2/1114 | Cancelled | Not determined | None |
| Adco terbinafine 1 % EACH 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | 1 % | 42012942/20.2.2/0129 | Registered | Not determined | None |
| AURO terbinafine tablets 125 MG EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 125,0 mg | 125 mgTablets | 42027142/20.2.2/0271 | Cancelled | Not determined | None |
| AURO terbinafine tablets 250 MG EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 mgTablets | 42027242/20.2.2/0272 | Cancelled | Not determined | None |
| Almatil 1 % cream EACH 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 10,0 mg | 1 %Cream | 42038242/20.2.2/0382 | Registered | Not determined | None |
| Lamibane 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | 42044642/20.2.2/0446 | Registered | Not determined | None |
| Binacil 125 MG EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 125,0 mg | 125 mg | 42047142/20.2.2/0471 | Registered | Not determined | None |
| Binacil 250 MG EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 mg | 42047242/20.2.2/0472 | Registered | Not determined | None |
| Adco-lamiderm 1 % EAC 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | 1 % | 42057242/20.2.2/0572 | Cancelled | Not determined | None |
| 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 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | A380397A38/20.2.2/0397 | Registered | Not determined | None |
| Terbicil EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | Not listed | A380484A38/20.2.2/0484 | Registered | Not determined | None |
| Terbinafine 250 MG viatris EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 mg | A380691A38/20.2.2/0691 | Registered | Not determined | None |
| Arrow terbinafine hci 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | A380697A38/20.2.2/0697 | 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 |
| Nafin 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | A390118A39/20.2.2/0118 | Registered | Not determined | None |
| Lamifem 1 % cream EACH 1,0 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | 1 %Cream | A390309A39/5.7.1/0309 | Registered | Not determined | None |
| Lamisil film forming solution EACH 1,0 g SOLUTION CONTAINS TERBINAFINE HYDROCHLORIDE 10,0 mg | Solution | A390439A39/20.2.2/0439 | Registered | Not determined | None |
| Lamispor 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | A400614A40/20.2.2/0614 | Registered | Not determined | None |
| Cipla-terbinafine 250 EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO TERBINAFINE 250,0 mg | 250 | A400615A40/20.2.2/0615 | Cancelled | Not determined | None |
| Lamisil 250 MG EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO 250 mg TERBINAFINE | 250 mg | Z0185Z/20.2.2/185 | Registered | Not determined | None |
| Lamisil 1% EACH 1 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10 mg | 1%Tablet | Z0186Z/20.2.2/186Approved 5 December 2024 | 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 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.
SAHPRA documents
Schedule Verification
Terbane nail, Sandoz South Africa (Pty) Ltd is scheduled S1 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.