ENBREL

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

Active ingredients

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

1	Etanercept UNII OP401G7OJC - ETANERCEPT
	Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
	Read more about Etanercept

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ENBREL Powder for solution for injection	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
L04AB01	Etanercept	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AB Tumor necrosis factor alpha (TNF-α) inhibitors
Discover more medicines within L04AB01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AL	Fondi i Sigurimit të Detyrueshëm të Kujdesit Shëndetësor	663/96
AU	Pharmaceutical Benefits Scheme	11196G, 11197H, 11198J, 11201M, 11204Q, 11207W, 11208X, 11219L, 11220M, 11222P, 11223Q, 11224R, 1954W, 1963H, 1964J, 3445H, 3446J, 3447K, 3448L, 3449M, 3450N, 5733R, 5734T, 5735W, 6367D, 8637N, 8638P, 8778B, 8779C, 9035M, 9036N, 9037P, 9085E, 9086F, 9087G, 9088H, 9089J, 9090K, 9091L, 9429G, 9431J, 9455P, 9456Q, 9457R, 9458T, 9459W, 9460X, 9461Y, 9462B, 9615C, 9641K
BR	Câmara de Regulação do Mercado de Medicamentos	552817080001717, 552817090002217, 552817090002317, 552817090002417, 552817090002517, 552817090002817, 552817090002917, 552818090064903, 552818090065003, 552818090065103, 552818090065203
CA	Health Products and Food Branch	02242903, 02274728
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00021640, 00021657, 00099889, 00121620, 00671912, 00676660, 00762460, 00970879, 01189991, 01440327, 02199425, 02199431, 02239159, 02241067, 02241073, 02241096, 02241104, 02241110, 02291510, 02847427, 02953365, 03004292, 03323844, 03752953, 03753289, 03753295, 03864267, 04227108, 04422407, 04425423, 04426055, 04427132, 04428367, 04446342, 04446359, 04492419, 04492425, 04537317, 04780302, 04973490, 04977039, 05541309, 05958481, 05958498, 06057047, 06093020, 06129344, 06129350, 06142741, 06152685, 06161916, 06161922, 06407671, 06452938, 06452944, 06497668, 06680059, 06934554, 06934560, 07753435, 07753441, 08929617, 09008233, 09008256, 09236218, 09334518, 09392906, 09521309, 09635585, 09635591, 09635616, 09637348, 09640439, 09640474, 09708781, 09782636, 09782642, 09893985, 10079623, 10221009, 10399380, 10709082, 10709099, 10709107, 10709113, 10786243, 10786266, 10813299, 10933000, 10933017, 11479282, 12521709, 12521721, 12521738, 12571357, 12571363, 13243767, 13243773, 13243796, 13243804, 13246493, 13246530, 13785965, 14139919, 14139931, 14139948, 14227138, 14227428, 14327986, 14328000, 14328017, 15235944, 15235967, 15609161, 15609178, 15612720, 16165921, 16680468, 16680474, 16743973, 16744010, 16754847, 16909534, 16913211, 17147635
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	109-MBE-0817, 140-MBE-0619
EE	Ravimiamet	1011665, 1209608, 1209619, 1209620, 1209631, 1209642, 1209653, 1209664, 1209675, 1213333, 1265600, 1265611, 1265622, 1265633, 1265644, 1265655, 1460180, 1460191, 1460203, 1538704, 1762253, 1762264, 1762275, 1777811
ES	Centro de información online de medicamentos de la AEMPS	199126023, 99126003, 99126013, 99126017, 99126020, 99126022
FI	Lääkealan turvallisuus- ja kehittämiskeskus	047042, 047560, 065778, 416609, 487692, 566661
FR	Base de données publique des médicaments	61187835, 63886766, 64959320, 66393935, 68667580, 68672848
GB	Medicines & Healthcare Products Regulatory Agency	109678, 110336, 159804, 199215, 348341, 41567
HK	Department of Health Drug Office	48914, 55983, 55984, 59796
IE	Health Products Regulatory Authority	88039, 88095, 88098, 88099, 88245, 88246, 88863
IL	מִשְׂרַד הַבְּרִיאוּת	4638, 7335, 7549, 7550
JP	医薬品医療機器総合機構	3999424D1029, 3999424D2025, 3999424G1025, 3999424G2021, 3999424G3028, 3999424G4024, 3999424G5020, 3999424G6027
LT	Valstybinė vaistų kontrolės tarnyba	1027990, 1027991, 1027992, 1027993, 1027994, 1027995, 1027996, 1027998, 1027999, 1028000, 1028001, 1028002, 1028003, 1028004, 1061303, 1076376, 1076377, 1076378, 1084548, 1084549, 1085078, 1085079, 1085080, 1085944
NL	Z-Index G-Standaard	15208826, 15208850, 15448037
NL	Z-Index G-Standaard, PRK	148032, 66125, 81647, 81655
NZ	Medicines and Medical Devices Safety Authority	12348, 12349, 8765
PL	Rejestru Produktów Leczniczych	100211923, 100226362, 100226379, 100226385, 100226416, 100250886, 100417530
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64809001, W64810001, W64811002, W64812002
SG	Health Sciences Authority	11854P, 13834P, 13835P, 14440P
TN	Direction de la Pharmacie et du Médicament	8013111H, 8013112H
TR	İlaç ve Tıbbi Cihaz Kurumu	8681308277435, 8681308955043, 8681308955050, 8681308955555, 8681308958600, 8681308959133, 8681308959140
US	FDA, National Drug Code	50090-4490, 58406-010, 58406-021, 58406-032, 58406-044, 58406-055, 58406-435, 58406-445, 58406-446, 58406-455, 58406-456
ZA	Health Products Regulatory Authority	34/3.1/0330, 41/3.1/0762, 41/3.1/0763