HUMIRA

This brand name is authorized in 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 HUMIRA contains one active pharmaceutical ingredient (API):

1
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 more about Adalimumab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 HUMIRA 40mg/0.4ml Solution for injection in pre-filled syringe / pen MPI, EU: SmPC European Medicines Agency (EU)
 HUMIRA 40mg/0.8ml Solution for injection in pre-filled syringe / pen MPI, EU: SmPC European Medicines Agency (EU)
 HUMIRA 20mg Solution for injection in pre-filled syringe MPI, EU: SmPC European Medicines Agency (EU)
 HUMIRA 80mg Solution for injection in pre-filled syringe / pen MPI, EU: SmPC European Medicines Agency (EU)
 HUMIRA 40mg/0.8ml 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
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)
AU Pharmaceutical Benefits Scheme 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
BR Câmara de Regulação do Mercado de Medicamentos 543715100001817, 543715100001917, 543715110002403, 543718020002703, 543718020002803, 543718020002903, 543718020003003, 543718020003103, 543718020003203, 543718050003403
CA Health Products and Food Branch 02258595, 02474263
DE Bundesinstitut für Arzneimittel und Medizinprodukte 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
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 108-MBE-0817, H5330613
EE Ravimiamet 1199549, 1199550, 1199561, 1199572, 1205637, 1470316, 1470327, 1470473, 1470484, 1695089, 1695090, 1695102, 1695113, 1715240, 1715251, 1715262, 1715273, 1747267, 1752971, 1766662, 1796069
ES Centro de información online de medicamentos de la AEMPS 103256013, 103256017, 103256021, 103256022
FI Lääkealan turvallisuus- ja kehittämiskeskus 013544, 034685, 072770, 434559, 477362, 516783, 517641
FR Base de données publique des médicaments 62975984, 64783769, 65325739, 69835440, 69847318
GB Medicines & Healthcare Products Regulatory Agency 328818, 328822, 353154, 362437
HK Department of Health Drug Office 65214, 65215, 67138
IE Health Products Regulatory Authority 88565, 88570, 88879, 88892
IL מִשְׂרַד הַבְּרִיאוּת 8028, 8515, 8561, 8968
JP 医薬品医療機器総合機構 3999426G3027, 3999426G4023, 3999426G5020, 3999426G6026, 3999426G7022
LT Valstybinė vaistų kontrolės tarnyba 1028727, 1028728, 1028729, 1028730, 1028731, 1028732, 1028733, 1028734, 1028735, 1028736, 1078871, 1078872, 1078873, 1078874, 1079689, 1079690, 1079691, 1079692, 1082614, 1084333, 1084434, 1085960
NL Z-Index G-Standaard, PRK 129771, 129798, 146153, 146781, 148822
NZ Medicines and Medical Devices Safety Authority 10791, 12494, 14425, 18211, 18212, 20005, 20006, 20007
PL Rejestru Produktów Leczniczych 100087630, 100362289, 100387183, 100396822
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64674001, W64708001, W64709001, W64710001, W64711001
SG Health Sciences Authority 12360P, 14626P, 15248P, 15718P, 15786P, 15787P
TN Direction de la Pharmacie et du Médicament 15623011H, 16913031H
TR İlaç ve Tıbbi Cihaz Kurumu 8680656080087, 8680656080285, 8680656080414, 8680656080421, 8680656080513
ZA Health Products Regulatory Authority 37/30.2/0252

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