HUMIRA

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

Active ingredients

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

1 Adalimumab UNII FYS6T7F842 - ADALIMUMAB

Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM). Read about Adalimumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
HUMIRA 40mg/0.4ml Solution for injection in pre-filled syringe / pen	European Medicines Agency (EU)	MPI, EU: SmPC
HUMIRA 40mg/0.8ml Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC
HUMIRA 80mg Solution for injection in pre-filled syringe / pen	European Medicines Agency (EU)	MPI, EU: SmPC
HUMIRA 20mg Solution for injection in pre-filled syringe	European Medicines Agency (EU)	MPI, EU: SmPC
HUMIRA 40mg/0.8ml Solution for injection in pre-filled syringe / pen	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
L04AB04	Adalimumab	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AB Tumor necrosis factor alpha (TNF-α) inhibitors
Discover more medicines within L04AB04

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): 12335F, 12336G, 12337H, 12338J, 12339K, 12340L, 12341M, 12342N, 12343P, 12344Q, 12345R, 12346T, 12347W, 12358K, 12359L, 12360M, 12361N, 12362P, 12363Q, 12364R, 12371D, 12372E, 12373F, 12374G, 12375H, 12376J, 12377K, 12378L, 12379M, 12380N, 12381P, 12382Q, 12383R, 12389C, 12390D, 12391E, 12392F, 12393G, 12394H, 12395J, 12396K, 12397L, 12398M, 12399N, 12400P, 12404W, 12405X, 12406Y, 12407B, 12408C, 12409D, 12410E, 12411F, 12412G, 12413H, 12414J, 12418N, 12419P, 12421R, 12422T, 12423W, 12424X, 12425Y, 12426B, 12427C, 12428D, 12429E, 12430F, 12431G, 12432H, 12433J, 12441T, 12442W, 12443X, 12444Y, 12445B, 12446C, 12447D, 12448E, 12449F, 12450G, 12451H, 12452J, 12453K, 12454L, 12455M, 12524E
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 543715100001817, 543715100001917, 543715110002403, 543718020002703, 543718020002803, 543718020002903, 543718020003003, 543718020003103, 543718020003203, 543718050003403
Country: CA	Health Products and Food Branch	Identifier(s): 02258595, 02474263
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 07764249, 07764255, 09635639, 09635645, 09635651, 09635668, 09635674, 11515233, 11515256, 11515262, 11515279, 12449716, 12468398, 12468406, 12468412, 12468429, 12470550, 12470573, 12471383, 12471408, 12471414, 12472052, 12472075, 12472081, 12472566, 12472572, 12472589, 12472595, 12473577, 12473583, 12473608, 12473614, 12478072, 12478089, 12478103, 12478126, 12504728, 12504734, 12504740, 12504757, 12529912, 12529929, 12562051, 12562068, 12562105, 12562140, 12580959, 12580971, 12580988, 12580994, 12589914, 12700978, 12701392, 12728646, 13248026, 13248032, 13516886, 13625233, 13625256, 13904453, 13946339, 13946345, 14032570, 14062364, 14139983, 14140012, 14168660, 14172207, 14172213, 14227256, 14227262, 14241285, 14257530, 14277426, 14277432, 14288826, 14289671, 14293709, 14299416, 14299422, 14304749, 14309072, 14309089, 14324083, 14366905, 14372484, 15201224, 15241413, 15375183, 15375208, 15375214, 15398669, 15398675, 15434075, 15619521, 15619857, 15619863, 15619886, 15619892, 15619900, 15625651, 15996614, 16586189, 16666190, 16743849, 16743884, 16743890, 16743921, 16789136, 16789165, 16789171, 16789188, 16840009, 16840015, 16868516, 16890504, 16890533, 17154813, 17312548
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 108-MBE-0817, H5330613
Country: EE	Ravimiamet	Identifier(s): 1199549, 1199550, 1199561, 1199572, 1205637, 1470316, 1470327, 1470473, 1470484, 1695089, 1695090, 1695102, 1695113, 1715240, 1715251, 1715262, 1715273, 1747267, 1752971, 1766662, 1796069
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 103256013, 103256017, 103256021, 103256022
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 013544, 034685, 072770, 434559, 477362, 516783, 517641
Country: FR	Base de données publique des médicaments	Identifier(s): 62975984, 64783769, 65325739, 69835440, 69847318
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 328818, 328822, 353154, 362437
Country: HK	Department of Health Drug Office	Identifier(s): 65214, 65215, 67138
Country: IE	Health Products Regulatory Authority	Identifier(s): 88565, 88570, 88879, 88892
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8028, 8515, 8561, 8968
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999426G3027, 3999426G4023, 3999426G5020, 3999426G6026, 3999426G7022
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1028727, 1028728, 1028729, 1028730, 1028731, 1028732, 1028733, 1028734, 1028735, 1028736, 1078871, 1078872, 1078873, 1078874, 1079689, 1079690, 1079691, 1079692, 1082614, 1084333, 1084434, 1085960
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 129771, 129798, 146153, 146781, 148822
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 10791, 12494, 14425, 18211, 18212, 20005, 20006, 20007
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100087630, 100362289, 100387183, 100396822
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64674001, W64708001, W64709001, W64710001, W64711001
Country: SG	Health Sciences Authority	Identifier(s): 12360P, 14626P, 15248P, 15718P, 15786P, 15787P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 15623011H, 16913031H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8680656080087, 8680656080285, 8680656080414, 8680656080421, 8680656080513
Country: ZA	Health Products Regulatory Authority	Identifier(s): 37/30.2/0252