TOPAMAX

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

Active ingredients

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

1	Topiramate UNII 0H73WJJ391 - TOPIRAMATE
	Topiramate is classified as a sulfamate-substituted monosaccharide. The precise mechanism by which topiramate exerts its antiseizure and migraine prophylaxis effects are unknown.
	Read more about Topiramate

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
B4-8211	Tablet	TOPAMAX 25 MG TABLET TAB 25 mg 1 X 60	106 RNW-PP-296584 TOPAMAX 25 MG TABLET TOPIRAMATE Each tablet contains 25 mg Topiramate. Excipients include - core tablet: lactose monohydrate, pregelatinized maize starch,microcrystalline cellulose sodium starch glycolate (Type A),magnesium stearate - film-coating: OPADRY? white, yellow, pink1, carnauba wax 1OPADRY? contains hypromellose, macrogol, polysorbate 80 and as colourants titanium dioxide E171 (all strengths), iron oxide yellow E172 (50 and 100 mg), and iron oxide red E172 (200 mg) B4-8211 Drugs NERVOUS SYSTEM Imported Products 160 POM 2 11/28/2022 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 DL-CONZACTCTRegulatoryAffairs@JNJZA.JNJ.com Cilag AG, Cilag AG, Hochstrasse 201, 8200 schaffhausen, Switzerland, Switzerland	28/03/2023
B4-8212	Tablet	TOPAMAX 50 MG TABLETS TAB 50 mg 60	61 RNW-PP-303391 TOPAMAX 50 MG TABLETS TOPIRAMATE Each tablet contains 50 mg topiramate, the other ingredients are - core tablet: lactose monohydrate, pregelatinized maize starch,microcrystalline cellulose sodium starch glycolate (Type A),magnesium stearate - film-coating: OPADRY? white, yellow, pink1, carnauba wax B4-8212 Drugs Imported Products 60 POM 2 12/28/2022 J & J COMPANY WEST AFRICA LIMITED, SINARI DARANIJO STREET, VICTORIA ISLAND LAGOS LAGOS 9062881239 DL-CONZACTCTRegulatoryAffairs@JNJZA.JNJ.com Cilag AG, Cilag AG, Hochstrasse 201, 8200 schaffhausen, Switzerland, Switzerland	06/07/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TOPAMAX Film-coated 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
N03AX11	Topiramate	N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AX Other antiepileptics
Discover more medicines within N03AX11

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	8163P, 8164Q, 8165R, 8166T, 8371N, 8372P, 8520K
BR	Câmara de Regulação do Mercado de Medicamentos	514504901119317, 514504903111313, 514504904118311, 514504905114311, 514517020032903
CA	Health Products and Food Branch	02230893, 02230894, 02230896, 02239907, 02239908
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00026643, 00026672, 00026695, 00026703, 00026726, 00753952, 00753969, 00753981, 00754006, 01266958, 01469147, 01986552, 03189794, 03193614, 03390390, 03497314, 03497320, 03497550, 03497739, 03497745, 05524883, 06833988, 13780608, 13780614
EE	Ravimiamet	1076666, 1076688, 1076712, 1076734, 1076756, 1076778, 1076813, 1076846, 1504538, 1504549, 1504550, 1504561, 1504572, 1504583, 1504594, 1504606, 1504617, 1504628, 1504639, 1504640, 1504651, 1504662, 1504673, 1504684, 1504695, 1504707, 1504718, 1504729, 1622168, 1622179, 1622180, 1622191
ES	Centro de información online de medicamentos de la AEMPS	61873, 61874, 61875, 61876, 63957, 63959, 63960
GB	Medicines & Healthcare Products Regulatory Agency	146729, 146731, 162768, 162773, 162776, 175960, 175965, 182022, 200287, 21876, 21877, 21880, 21881, 369018, 369020, 373513, 373515, 373526, 373530, 373533, 373833, 374147, 377309, 377312, 377315, 42055, 42061, 42066
HK	Department of Health Drug Office	42315, 42316, 42317
HR	Agencija za lijekove i medicinske proizvode	HR-H-239773821, HR-H-610277393, HR-H-668959661, HR-H-839682871
IE	Health Products Regulatory Authority	13184, 13185, 31144, 62457, 69902, 69914, 69922, 69926, 69938, 69947, 69953, 69959, 69992
IL	מִשְׂרַד הַבְּרִיאוּת	3549, 3550, 3551, 3552
IT	Agenzia del Farmaco	032023020, 032023032, 032023044, 032023071, 032023095
LT	Valstybinė vaistų kontrolės tarnyba	1003184, 1003186, 1003188, 1003192, 1005407, 1072705, 1072706, 1072707, 1072708
MT	Medicines Authority	MA018/00301, MA018/00302, MA018/00303, MA018/00304, MA018/00305, MA018/00306, MA018/00307
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	406M99, 437M97
NG	Registered Drug Product Database	B4-8211, B4-8212
NL	Z-Index G-Standaard, PRK	43990, 45756, 45764, 66087, 66095, 89397
NZ	Medicines and Medical Devices Safety Authority	7646, 7648, 7649, 7650, 8303, 8304, 8305
PL	Rejestru Produktów Leczniczych	100080243, 100080250, 100080266, 100080272, 100100187, 100239459
SG	Health Sciences Authority	09687P, 09688P, 09689P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593095061, 8699593095078, 8699593095085, 8699593095092
US	FDA, National Drug Code	50458-639, 50458-640, 50458-641, 50458-642, 50458-645, 50458-647, 55289-433, 70518-2165, 70518-2753
ZA	Health Products Regulatory Authority	30/2.5/0236, 30/2.5/0237, 30/2.5/0238, 30/2.5/0239, 32/2.5/0662, 32/2.5/0663, 32/2.5/0664