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Lamisil

Terbinafine

S4Read from the PI-PIL document and verified
Loading the molecular structure
C21H25N291.40 g/mol

(E)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine

Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 1549008.

Registration

Applicants
2
Registrations
3
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Adcock ingram limitedCertificate held by Novartis south africaLamisil1 %, 1%310613, Z0186S4PIPIL
Novartis South Africa (Pty) LtdLamisil250 mgZ0185Not determinedPIPIL

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Lamisil 1 % spray

EACH 1 g SPRAY SOLUTION CONTAINS TERBINAFINE 10,0 mg

1 %Spray31061331/20.2.2/0613RegisteredNot determinedNone
Lamisil 250 MG

EACH TABLET CONTAINS TERBINAFINE HYDROCHLORIDE EQUIVALENT TO 250 mg TERBINAFINE

250 mgZ0185Z/20.2.2/185RegisteredNot determinedPIPIL
Lamisil 1%

EACH 1 g CREAM CONTAINS TERBINAFINE HYDROCHLORIDE 10 mg

1%TabletZ0186Z/20.2.2/186Approved 5 December 2024RegisteredS4PIPIL

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.

Background

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SAHPRA documents

Research articles

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