TOPAMAX

This brand name is authorized in United States. 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, Nigeria, Poland, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1
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

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
Switch country to Nigeria in order to find specific presentations of TOPAMAX
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

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