TREMFYA

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

Active ingredients

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

1 Guselkumab UNII 089658A12D - GUSELKUMAB

Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity. IL-23, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. In humans, selective blockade of IL-23 was shown to normalize production of these cytokines. Read about Guselkumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
TREMFYA Solution for injection	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
L04AC16		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors
Discover more medicines within L04AC16

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): 11614G, 12568L, 12590P
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514518070034802, 514521010038402
Country: CA	Health Products and Food Branch	Identifier(s): 02469758, 02487314
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 164-MBE-0920
Country: EE	Ravimiamet	Identifier(s): 1756953, 1800470, 1800481, 1827132
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171234001, 1171234002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 402801, 502843
Country: FR	Base de données publique des médicaments	Identifier(s): 67296108, 68372441
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 358534
Country: HK	Department of Health Drug Office	Identifier(s): 65944, 67037
Country: IE	Health Products Regulatory Authority	Identifier(s): 88939
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8201, 8898
Country: IT	Agenzia del Farmaco	Identifier(s): 045772011, 045772023, 045772035, 045772047
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1084491, 1086141, 1087932, 1089197
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 148687, 153567
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100398181
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65090001, W65090002
Country: SG	Health Sciences Authority	Identifier(s): 15508P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699593000003, 8699593000010, 8699593950124
Country: US	FDA, National Drug Code	Identifier(s): 57894-640