FYCOMPA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, South Africa, Spain, UK.

Active ingredients

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

1
UNII H821664NPK - PERAMPANEL
 

Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons. Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation. The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.

 
Read more about Perampanel

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 FYCOMPA Film-coated tablet MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

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

ATC Group Classification
N03AX22 Perampanel N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AX Other antiepileptics
Discover more medicines within N03AX22

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 10151G, 10157N, 10159Q, 10160R, 10162W, 10163X, 11407J, 11409L, 11418Y, 11428L, 11429M, 11436X
BR Câmara de Regulação do Mercado de Medicamentos 533220060002917, 533220060003017, 533220060003117, 533220060003217, 533220060003317, 533220060003417
CA Health Products and Food Branch 02404516, 02404524, 02404532, 02404540, 02404559, 02404567
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 5538-MEE-1020, 5545-MEE-1020, 5555-MEE-1020, 5561-MEE-1020
EE Ravimiamet 1589902, 1589913, 1589924, 1589935, 1589946, 1589957, 1589968, 1589979, 1589980, 1589991, 1590005, 1590016, 1590027, 1590038, 1590049, 1590050, 1597877, 1597888, 1597901, 1597912, 1597923, 1597934, 1597945, 1729302
ES Centro de información online de medicamentos de la AEMPS 112776024, 12776001, 12776003, 12776006, 12776009, 12776012, 12776015
FI Lääkealan turvallisuus- ja kehittämiskeskus 064053, 169621, 375202, 432761, 475696, 506125, 560666
FR Base de données publique des médicaments 61849146, 63602479, 64387360, 65931110, 68328199, 69856153
GB Medicines & Healthcare Products Regulatory Agency 212122, 212128, 212131, 212134, 212137, 212140, 297739, 367771, 368022, 368024, 368026, 368028, 368030, 368032, 374383, 381368, 381370, 381372, 381374, 381376, 381378
HK Department of Health Drug Office 62759, 62760, 62761, 62762, 62763, 62764
IE Health Products Regulatory Authority 43760, 43761, 43762, 43763, 43764, 43765, 43783, 43784, 43785, 43786, 43787, 43788, 43790, 43792, 43973
IL מִשְׂרַד הַבְּרִיאוּת 7262, 7263, 7264, 7265, 7266, 7267, 9340
JP 医薬品医療機器総合機構 1139014C1026, 1139014F1022, 1139014F2029
LT Valstybinė vaistų kontrolės tarnyba 1067139, 1067140, 1067141, 1067142, 1067143, 1067144, 1067145, 1067146, 1067147, 1067148, 1067149, 1067150, 1067151, 1067152, 1067153, 1067154, 1068415, 1068416, 1068417, 1068418, 1068419, 1068420, 1068421, 1081755
NL Z-Index G-Standaard, PRK 115460, 115479, 115487, 115495, 115509, 115517, 197084
NZ Medicines and Medical Devices Safety Authority 21106, 21107, 21108, 21109, 21110, 21111, 22305
PL Rejestru Produktów Leczniczych 100309786, 100309792, 100309800, 100309817, 100309823, 100309830, 100383268
SG Health Sciences Authority 14616P, 14617P, 14618P, 14619P, 14620P, 14621P
US FDA, National Drug Code 62856-272, 62856-274, 62856-276, 62856-278, 62856-280, 62856-282, 62856-290
ZA Health Products Regulatory Authority 47/2.5/1196, 47/2.5/1197, 47/2.5/1198, 47/2.5/1199, 47/2.5/1200, 47/2.5/1201

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