XELJANZ

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

Active ingredients

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

1 Tofacitinib UNII O1FF4DIV0D - TOFACITINIB CITRATE

Tofacitinib is a potent, selective inhibitor of the JAK family. In human cells, tofacitinib preferentially inhibits signalling by heterodimeric cytokine receptors that associate with JAK3 and/or JAK1. Inhibition of JAK1 and JAK3 by tofacitinib attenuates signalling of interleukins and type I and type II interferons, which will result in modulation of the immune and inflammatory response. Read about Tofacitinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
XELJANZ Film-coated tablet	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
L04AF01		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AF Janus-associated kinase (JAK) inhibitors
Discover more medicines within L04AF01

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): 10511F, 10517M, 11675L, 11690G, 12556W, 12557X, 12588M, 12589N
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 522720060088617, 522720110090507
Country: CA	Health Products and Food Branch	Identifier(s): 02423898, 02470608, 02480786
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 172-MEE-0314, 4452-MEE-1018
Country: EE	Ravimiamet	Identifier(s): 1742497, 1742509, 1742510, 1775022, 1790377, 1790388, 1790401, 1790412, 1790423, 1809053, 1809064, 1809075, 1809086, 1809334, 1859991
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1171178003, 1171178007
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 094146, 128750, 478177, 591405
Country: FR	Base de données publique des médicaments	Identifier(s): 61342424, 66610933, 68330200
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 342760, 357259, 381012
Country: HK	Department of Health Drug Office	Identifier(s): 63303, 66141, 66833
Country: IE	Health Products Regulatory Authority	Identifier(s): 88874, 89024, 89036
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7422, 9288, 9289
Country: IT	Agenzia del Farmaco	Identifier(s): 045320013, 045320025, 045320037, 045320049, 045320052, 045320064, 045320076, 045320088, 045320090, 045320102, 045320114, 045320126, 045320138, 045320140, 045320153
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999034F1020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1082650, 1082651, 1082652, 1085098, 1086551, 1086552, 1086553, 1086554, 1086555, 1086556, 1089144, 1089145, 1089146, 1089147, 1093294
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 142468, 151998, 201502
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100386232, 100411964, 100413153, 100433820
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W65118001, W66577001, W66577002, W68697001
Country: SG	Health Sciences Authority	Identifier(s): 14664P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 20473011
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681308031044, 8681308090003
Country: US	FDA, National Drug Code	Identifier(s): 0069-0501, 0069-0502, 0069-1001, 0069-1002, 63539-012, 63539-016, 63539-501, 63539-502
Country: ZA	Health Products Regulatory Authority	Identifier(s): 47/3.1/1156