REMICADE

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, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK, United States.

Active ingredients

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

1
UNII B72HH48FLU - INFLIXIMAB
 

Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFβ).

 
Read more about Infliximab

Packages

This drug has been approved in Nigeria as follows:

Identifier Form Presentation Description Approval
A6-0490 Powder for solution for injection/infusion Remicade INJ_PWD_F_SOL 100 mg 100mg x 1 Formulated Powder for concentrate for solution for infusion (powder for concentrate). The powder is a freeze-dried white pellet. 27/06/2023

Medicine classification

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

ATC Group Classification
L04AB02 Infliximab L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AB Tumor necrosis factor alpha (TNF-α) inhibitors
Discover more medicines within L04AB02

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 10057H, 10067W, 10184B, 10196P, 11389K, 11399Y, 11412P, 11424G, 11445J, 11448M, 11459D, 11481G, 11482H, 11487N, 11489Q, 11497D, 11498E, 11590B, 11606W, 11797X, 4284L, 5753T, 5754W, 5755X, 5756Y, 5757B, 5758C, 6397Q, 6448J, 6496X, 9612X, 9613Y, 9617E, 9654D, 9674E
BR Câmara de Regulação do Mercado de Medicamentos 514512080025214
CA Health Products and Food Branch 02244016
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00067808, 00072181, 00200213, 00200236, 01359648, 01359654, 01557414, 01574335, 02001630, 02001653, 02144565, 02144571, 02645356, 02645362, 03332091, 03572300, 03572317, 03741240, 03767883, 04113876, 05461591, 05497293, 05497301, 05515795, 05515803, 05874034, 05874040, 06105800, 06105817, 06113343, 06140110, 06407180, 06453607, 06464752, 06464769, 06561395, 06561403, 06765778, 06939959, 07510371, 07796404, 08453557, 08453563, 08453586, 08453592, 09094876, 09245140, 10709231, 10822631, 10978899, 10985942, 11022507, 11024185, 11072511, 11078353, 11098580, 12444400, 12444417, 13582908, 14227434, 14259948, 14259954, 14277656, 15390053, 15390076, 15390082, 15390099, 15390107, 15433911, 15433928, 15433934, 15559919, 15658165, 15658171, 15658188, 15658194, 16383233, 16451822, 16451845, 16667367, 16743737, 16743743, 16743766, 16830092, 16830100
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 57-MBE-0516
EE Ravimiamet 1010833, 1111116, 1111127, 1430648, 1430659
ES Centro de información online de medicamentos de la AEMPS 99116001
FI Lääkealan turvallisuus- ja kehittämiskeskus 063187, 575787
FR Base de données publique des médicaments 64542736
GB Medicines & Healthcare Products Regulatory Agency 392468, 43981
HK Department of Health Drug Office 54964
IL מִשְׂרַד הַבְּרִיאוּת 4184
IT Agenzia del Farmaco 034528012
JP 医薬品医療機器総合機構 2399402F1026
LT Valstybinė vaistų kontrolės tarnyba 1007116, 1030651, 1030652, 1036689, 1036690
NG Registered Drug Product Database A6-0490
NL Z-Index G-Standaard, PRK 54542
NZ Medicines and Medical Devices Safety Authority 8822
PL Rejestru Produktów Leczniczych 100104274
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W57617001, W57617002, W57617003, W57617004, W57617005
SG Health Sciences Authority 12120P
TN Direction de la Pharmacie et du Médicament 1923011H
TR İlaç ve Tıbbi Cihaz Kurumu 8699636790380
US FDA, National Drug Code 57894-030

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