KEPPRA

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, Mexico, Netherlands, Poland, Singapore, South Africa, Spain, Tunisia, Turkey, UK, United States.

Active ingredients

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

1	Levetiracetam UNII 44YRR34555 - LEVETIRACETAM
	Levetiracetam, is a pyrrolidone derivative, chemically unrelated to existing antiepileptic active substances. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive.
	Read more about Levetiracetam

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-7333	Film coated tablet	KEPPRA LEVETIRACETAM 250MG TABLET TAB_FILM_COATED 250 mg 6X10	56 RNW-PP-309893 KEPPRA LEVETIRACETAM 250MG TABLET 250mg Levetiracetam Film-coated Tablets A4-7333 Drugs Imported Products 610tablets Prescription Only Medicine (POM) 2/1/2023 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD., INDUSTRIAL AVENUE ILUPEJU LAGOS 12711000 delphine.u.onyeaso@gsk.com UCB Pharma S.A., Chemin du Foriest, B-1420, Braine L'Alleud, Belgium, UCB Pharma S.A., Chemin du Foriest, B-1420, Braine L'Alleud, Belgium, Belgium	25/05/2023
A4-7334	Film coated tablet	KEPPRA LEVETIRACETAM 500MG TAB_FILM_COATED 500 mg 610tablets	KEPPRA LEVETIRACETAM 500MG 500 mg of levetiracetam A4-7334 Drugs Imported Products 610tablets POM 1 01/02/2023 GLAXOSMITHKLINE PHARMACEUTICAL NIGERIA LTD., INDUSTRIAL AVENUE ILUPEJU LAGOS 12711000 delphine.u.onyeaso@gsk.com UCB Pharma S.A., Chemin du Foriest, B-1420, Braine L'Alleud, Belgium, UCB Pharma S.A., Chemin du Foriest, B-1420, Braine L'Alleud, Belgium, Belgium	25/05/2023

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KEPPRA Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)
KEPPRA Concentrate for solution for infusion	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
N03AX14	Levetiracetam	N Nervous system → N03 Antiepileptics → N03A Antiepileptics → N03AX Other antiepileptics
Discover more medicines within N03AX14

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	8654L, 8655M, 8656N, 9169N
BR	Câmara de Regulação do Mercado de Medicamentos	525215120021102, 525215120021202, 525215120021302, 525215120021402, 525215120021502, 525220110025807, 525220110025907, 525220110026007, 525220110026107, 525221010026207, 525221010026307
CA	Health Products and Food Branch	02247027, 02247028, 02247029
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00025750, 00272655, 00272661, 00566115, 00780713, 00827260, 01170075, 01218008, 01218020, 01218037, 01218043, 01218066, 01218103, 01218132, 01218155, 01218178, 01557928, 01557940, 01626658, 01890533, 01890556, 01897570, 01897587, 01930126, 01930132, 02472186, 02478881, 03000940, 03177236, 03275370, 03412795, 03412803, 03444453, 03444795, 03444826, 03882590, 04011408, 04033775, 04121947, 04258965, 04258988, 04259077, 04259083, 04825163, 04970273, 05124497, 05453798, 05453806, 06793639, 07072936, 07377794, 08829229, 08829235, 09082815, 09225189, 09632730, 09632747, 09632753, 09686507, 09686513, 09686536, 10094284, 10147023, 10228804, 10319719, 10319725, 10795176, 11130740, 11485644, 11586351, 11613711, 14357875, 16017876, 16682183, 16783381, 17388698
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	1177-MEE-0715, 1179-MEE-0715, 1323-MEE-0915, 3149-MEE-0118
EE	Ravimiamet	1198751, 1198762, 1198773, 1198784, 1198795, 1198807, 1198818, 1198829, 1198830, 1198841, 1198852, 1198863, 1198874, 1198885, 1198896, 1198908, 1198919, 1198920, 1198931, 1198942, 1198953, 1198964, 1198975, 1198986, 1198997, 1199000, 1199011, 1199022, 1199033, 1354339, 1460247, 1874224
ES	Centro de información online de medicamentos de la AEMPS	00146004, 00146010, 00146010IP, 00146010IP1, 00146010IP2, 00146010IP3, 00146022, 00146022IP, 00146022IP1, 00146022IP2, 00146022IP4, 00146027, 00146031, 00146032, 100146033
FI	Lääkealan turvallisuus- ja kehittämiskeskus	003064, 003112, 003158, 014081, 071161, 071172, 499909
FR	Base de données publique des médicaments	60132330, 61901995, 65586187, 68596770, 68719194
GB	Medicines & Healthcare Products Regulatory Agency	104470, 139175, 139177, 142625, 142629, 142634, 147305, 161939, 174464, 174465, 180618, 182704, 182706, 182710, 185875, 185877, 21828, 21844, 36376, 368058, 368059, 368061, 368063, 368065, 375153, 375155, 375157, 375921, 375970, 376691, 376693, 376694, 376696, 376699, 377481, 379728, 379907, 379908, 379910, 379912, 381439, 387238, 390297, 390302, 390304, 81712, 81767
HK	Department of Health Drug Office	48230, 48231, 48232, 54926, 58176
IE	Health Products Regulatory Authority	16320, 16589, 22835, 22863, 30100, 30128, 30186, 30203, 30211, 30222, 30234, 30271, 30290, 30295, 30309, 30381, 30389, 51429, 51465, 51472, 51473, 54322, 54323, 54338, 54339, 54363, 54364, 54365
IL	מִשְׂרַד הַבְּרִיאוּת	4847, 4848, 4849, 6215
IT	Agenzia del Farmaco	035039104, 035039229, 035039270, 035039294, 035039306
JP	医薬品医療機器総合機構	1139010F1024, 1139010F2020, 1139010R1020, 1139402A1025
LT	Valstybinė vaistų kontrolės tarnyba	1028999, 1029000, 1029001, 1029002, 1029003, 1029004, 1029005, 1029006, 1029007, 1029008, 1029009, 1029010, 1029011, 1029012, 1029013, 1029014, 1029015, 1029016, 1029017, 1029018, 1029019, 1029020, 1029021, 1029022, 1029023, 1029024, 1029025, 1029026, 1029027, 1029028, 1050844, 1050845, 1068858, 1068859, 1068860, 1068861, 1068862, 1068863
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	038M2010, 069M2007, 314M2001
NG	Registered Drug Product Database	A4-7333, A4-7334
NL	Z-Index G-Standaard	15189740
NL	Z-Index G-Standaard, PRK	58386, 58394, 58408, 80918, 80926
PL	Rejestru Produktów Leczniczych	100104386, 100104392, 100104417, 100126732, 100126749, 100162076
SG	Health Sciences Authority	11685P, 11686P, 11687P, 13225P, 13730P
TN	Direction de la Pharmacie et du Médicament	3113021
TR	İlaç ve Tıbbi Cihaz Kurumu	8699624090065, 8699624090072, 8699624090089, 8699624650023, 8699624650061, 8699624650078, 8699624760012
US	FDA, National Drug Code	50474-001, 50474-002, 50474-594, 50474-595, 50474-596, 50474-597, 50474-598, 50474-599, 55289-097, 70518-2109
ZA	Health Products Regulatory Authority	36/2.5/0088, 36/2.5/0089, 36/2.5/0090, A40/2.5/0587