SIMPONI

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

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 about Golimumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SIMPONI 50mg 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
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)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11361Y, 11365E, 11372M, 11373N, 11375Q, 11376R, 11381B, 11382C, 11502J, 11516D, 11521J, 11538G, 11560K, 3426H, 3428K, 3430M, 3432P, 3434R, 3436W
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514513070026812, 514515030027502, 514517040033003, 514520070037607, 514521070039007
Country: CA	Health Products and Food Branch	Identifier(s): 02324776, 02324784, 02413175, 02413183, 02417472
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 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
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): H6320813
Country: EE	Ravimiamet	Identifier(s): 1456231, 1456242, 1456253, 1456264, 1647211, 1647222, 1647233, 1647244, 1789690
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 09546001, 09546005IP1, 109546005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 059353, 059364, 416533, 518270, 587522
Country: FR	Base de données publique des médicaments	Identifier(s): 60035714, 62222050, 62534114, 67700426
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 180356, 180359, 239829
Country: HK	Department of Health Drug Office	Identifier(s): 59900, 63606, 64294, 64295, 66453
Country: IE	Health Products Regulatory Authority	Identifier(s): 88331, 88512, 88513, 88900, 88994, 89020, 89096
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 6698, 7677, 8581
Country: IT	Agenzia del Farmaco	Identifier(s): 039541014, 039541026, 039541038, 039541040, 039541053, 039541065, 039541077, 039541089, 039541091
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999433G1024, 3999433G2020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1051075, 1051076, 1051077, 1051078, 1072073, 1072074, 1072075, 1072076, 1087075
Country: NL	Z-Index G-Standaard	Identifier(s): 15910164
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 105406, 134430, 93289
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 13592, 13596, 16556, 16557
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100213098, 100306658, 100434008
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W57619001, W57619002
Country: SG	Health Sciences Authority	Identifier(s): 14105P, 14734P, 14735P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 1923021H, 1923022H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699636651025, 8699636651032, 8699636651049, 8699636651056
Country: US	FDA, National Drug Code	Identifier(s): 57894-070, 57894-071, 57894-350
Country: ZA	Health Products Regulatory Authority	Identifier(s): 43/30.1/0808, 54/30.1/0804