SIMPONI

This brand name is authorized in United States. 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, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Golimumab UNII 91X1KLU43E - GOLIMUMAB
	Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
	Read more about Golimumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SIMPONI 50mg Solution for injection in pre-filled syringe / pen	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
L04AB06	Golimumab	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AB Tumor necrosis factor alpha (TNF-α) inhibitors
Discover more medicines within L04AB06

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	11361Y, 11365E, 11372M, 11373N, 11375Q, 11376R, 11381B, 11382C, 11502J, 11516D, 11521J, 11538G, 11560K, 3426H, 3428K, 3430M, 3432P, 3434R, 3436W
BR	Câmara de Regulação do Mercado de Medicamentos	514513070026812, 514515030027502, 514517040033003, 514520070037607, 514521070039007
CA	Health Products and Food Branch	02324776, 02324784, 02413175, 02413183, 02417472
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	01622608, 01786451, 01786534, 01786557, 01786586, 03277475, 03277558, 03297727, 03297733, 03297816, 03297905, 06090412, 06562087, 06926632, 06926649, 07693348, 07773484, 07773490, 09239381, 09321214, 09392119, 09617713, 10538864, 10551681, 10797301, 10797318, 10797324, 10797330, 11230140, 11362657, 11523250, 11537967, 11537973, 11599974, 11599980, 11599997, 11658553, 11658576, 11684177, 11684214, 11714240, 11714257, 12452463, 12452486, 12468375, 12595837, 13566938, 13566950, 13566967, 13566973, 13928790, 13928809, 13969151, 14025593, 14141448, 14212289, 14213716, 14213722, 14264501, 14264518, 14327584, 14357065, 14367431, 14418252, 15416083, 15416108, 15416114, 15416120, 15416137, 15609132, 15612430, 15895735, 15895801, 16144876, 16144882, 16144899, 16144907, 16383256, 16383262, 16567683, 16567708, 16657860, 16657877, 16684590, 16684609, 16803681, 16868539, 16875545, 16875551, 16897268, 16897305
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H6320813
EE	Ravimiamet	1456231, 1456242, 1456253, 1456264, 1647211, 1647222, 1647233, 1647244, 1789690
ES	Centro de información online de medicamentos de la AEMPS	09546001, 09546005IP1, 109546005
FI	Lääkealan turvallisuus- ja kehittämiskeskus	059353, 059364, 416533, 518270, 587522
FR	Base de données publique des médicaments	60035714, 62222050, 62534114, 67700426
GB	Medicines & Healthcare Products Regulatory Agency	180356, 180359, 239829
HK	Department of Health Drug Office	59900, 63606, 64294, 64295, 66453
IE	Health Products Regulatory Authority	88331, 88512, 88513, 88900, 88994, 89020, 89096
IL	מִשְׂרַד הַבְּרִיאוּת	6698, 7677, 8581
IT	Agenzia del Farmaco	039541014, 039541026, 039541038, 039541040, 039541053, 039541065, 039541077, 039541089, 039541091
JP	医薬品医療機器総合機構	3999433G1024, 3999433G2020
LT	Valstybinė vaistų kontrolės tarnyba	1051075, 1051076, 1051077, 1051078, 1072073, 1072074, 1072075, 1072076, 1087075
NG	Registered Drug Product Database	A6-0474
Switch country to Nigeria in order to find specific presentations of SIMPONI
NL	Z-Index G-Standaard	15910164
NL	Z-Index G-Standaard, PRK	105406, 134430, 93289
NZ	Medicines and Medical Devices Safety Authority	13592, 13596, 16556, 16557
PL	Rejestru Produktów Leczniczych	100213098, 100306658, 100434008
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W57619001, W57619002
SG	Health Sciences Authority	14105P, 14734P, 14735P
TN	Direction de la Pharmacie et du Médicament	1923021H, 1923022H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699636651025, 8699636651032, 8699636651049, 8699636651056
US	FDA, National Drug Code	57894-070, 57894-071, 57894-350
ZA	Health Products Regulatory Authority	43/30.1/0808, 54/30.1/0804