LAMISIL

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug LAMISIL contains one active pharmaceutical ingredient (API):

1	Terbinafine UNII 012C11ZU6G - TERBINAFINE HYDROCHLORIDE
	Terbinafine is an allylamine which has a broad spectrum of antifungal activity. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species.
	Read more about Terbinafine

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-0815	Tablet	Lamisil 250 Tablets TAB 250 mg	Tablet	21/12/2020

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
LAMISIL Tablet	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
D01AE15	Terbinafine	D Dermatologicals → D01 Antifungals for dermatological use → D01A Antifungals for topical use → D01AE Other antifungals for topical use
Discover more medicines within D01AE15
D01BA02	Terbinafine	D Dermatologicals → D01 Antifungals for dermatological use → D01B Antifungals for systemic use → D01BA Antifungals for systemic use
Discover more medicines within D01BA02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	2285G, 2804N, 4011D, 4463X, 4473K, 9160D
BR	Câmara de Regulação do Mercado de Medicamentos	526508006118310, 526508007114319
CA	Health Products and Food Branch	02031094, 02031116, 02238703
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00998375, 01713191, 04363159
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	24.842-12-02, 25.002-03-03, 29501-11-10
EE	Ravimiamet	1002766, 1002902, 1034345, 1061020, 1061031, 1061165, 1110485, 1229150, 1855166, 1873458, 1873469
ES	Centro de información online de medicamentos de la AEMPS	59434, 59435, 62782, 62783
FI	Lääkealan turvallisuus- ja kehittämiskeskus	011020, 066687, 069799, 096784
FR	Base de données publique des médicaments	65054729, 65918216, 66102835, 66387487
GB	Medicines & Healthcare Products Regulatory Agency	137934, 139195, 147553, 15844, 15845, 161964, 161965, 23606, 23607, 41281, 76653, 97807
HK	Department of Health Drug Office	43790, 44413, 45846, 56568, 58379, 63179
HR	Agencija za lijekove i medicinske proizvode	HR-H-344287404, HR-H-374155033, HR-H-798097379
IE	Health Products Regulatory Authority	30729, 30835, 30913, 30914, 30973, 31013, 31073
IL	מִשְׂרַד הַבְּרִיאוּת	2801, 5068, 5194, 5219, 5247
IT	Agenzia del Farmaco	028176028
JP	医薬品医療機器総合機構	2659710N1152, 2659710Q1078, 2659710R1049, 6290005F1024
LT	Valstybinė vaistų kontrolės tarnyba	1008181, 1008358, 1020019, 1022395, 1054394, 1061421, 1082642, 1088291, 1089504, 1093395
MT	Medicines Authority	MA1177/00901, MA1177/00902, MA1249/01001, PI908/02401A
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	030M93, 272M91
NG	Registered Drug Product Database	04-0815
NL	Z-Index G-Standaard, PRK	35157, 78220, 82449
NZ	Medicines and Medical Devices Safety Authority	11791, 13707, 6395, 6396, 6399, 8709, 8932
PL	Rejestru Produktów Leczniczych	100036696, 100036704
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W05806001, W63407001, W63407002
SG	Health Sciences Authority	06932P, 07623P, 10215P, 10304P, 10617P
TN	Direction de la Pharmacie et du Médicament	1623071, 9253461, 9253462
TR	İlaç ve Tıbbi Cihaz Kurumu	8681291650185
ZA	Health Products Regulatory Authority	31/20.2.2/0612, 32/20.2.2/0564, A39/20.2.2/0439, Z/20.2.2/184, Z/20.2.2/185, Z/20.2.2/186