ENBREL

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

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 about Etanercept

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
ENBREL Powder for solution for injection European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

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

ATC code Group title 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)
Country: AU Pharmaceutical Benefits Scheme Identifier(s): 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
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 552817080001717, 552817090002217, 552817090002317, 552817090002417, 552817090002517, 552817090002817, 552817090002917, 552818090064903, 552818090065003, 552818090065103, 552818090065203
Country: CA Health Products and Food Branch Identifier(s): 02242903, 02274728
Country: DE Bundesinstitut für Arzneimittel und Medizinprodukte Identifier(s): 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
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 109-MBE-0817, 140-MBE-0619
Country: EE Ravimiamet Identifier(s): 1011665, 1209608, 1209619, 1209620, 1209631, 1209642, 1209653, 1209664, 1209675, 1213333, 1265600, 1265611, 1265622, 1265633, 1265644, 1265655, 1460180, 1460191, 1460203, 1538704, 1762253, 1762264, 1762275, 1777811
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 199126023, 99126003, 99126013, 99126017, 99126020, 99126022
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 047042, 047560, 065778, 416609, 487692, 566661
Country: FR Base de données publique des médicaments Identifier(s): 61187835, 63886766, 64959320, 66393935, 68667580, 68672848
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 109678, 110336, 159804, 199215, 348341, 41567
Country: HK Department of Health Drug Office Identifier(s): 48914, 55983, 55984, 59796
Country: IE Health Products Regulatory Authority Identifier(s): 88039, 88095, 88098, 88099, 88245, 88246, 88863
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 4638, 7335, 7549, 7550
Country: JP 医薬品医療機器総合機構 Identifier(s): 3999424D1029, 3999424D2025, 3999424G1025, 3999424G2021, 3999424G3028, 3999424G4024, 3999424G5020, 3999424G6027
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1027990, 1027991, 1027992, 1027993, 1027994, 1027995, 1027996, 1027998, 1027999, 1028000, 1028001, 1028002, 1028003, 1028004, 1061303, 1076376, 1076377, 1076378, 1084548, 1084549, 1085078, 1085079, 1085080, 1085944
Country: NL Z-Index G-Standaard Identifier(s): 15208826, 15208850, 15448037
Country: NL Z-Index G-Standaard, PRK Identifier(s): 148032, 66125, 81647, 81655
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 12348, 12349, 8765
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100211923, 100226362, 100226379, 100226385, 100226416, 100250886, 100417530
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64809001, W64810001, W64811002, W64812002
Country: SG Health Sciences Authority Identifier(s): 11854P, 13834P, 13835P, 14440P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 8013111H, 8013112H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8681308277435, 8681308955043, 8681308955050, 8681308955555, 8681308958600, 8681308959133, 8681308959140
Country: US FDA, National Drug Code Identifier(s): 50090-4490, 58406-010, 58406-021, 58406-032, 58406-044, 58406-055, 58406-435, 58406-445, 58406-446, 58406-455, 58406-456
Country: ZA Health Products Regulatory Authority Identifier(s): 34/3.1/0330, 41/3.1/0762, 41/3.1/0763

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