XELJANZ

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

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 more about Tofacitinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
XELJANZ Film-coated tablet	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
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)
AU	Pharmaceutical Benefits Scheme	10511F, 10517M, 11675L, 11690G, 12556W, 12557X, 12588M, 12589N
BR	Câmara de Regulação do Mercado de Medicamentos	522720060088617, 522720110090507
CA	Health Products and Food Branch	02423898, 02470608, 02480786
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	172-MEE-0314, 4452-MEE-1018
EE	Ravimiamet	1742497, 1742509, 1742510, 1775022, 1790377, 1790388, 1790401, 1790412, 1790423, 1809053, 1809064, 1809075, 1809086, 1809334, 1859991
ES	Centro de información online de medicamentos de la AEMPS	1171178003, 1171178007
FI	Lääkealan turvallisuus- ja kehittämiskeskus	094146, 128750, 478177, 591405
FR	Base de données publique des médicaments	61342424, 66610933, 68330200
GB	Medicines & Healthcare Products Regulatory Agency	342760, 357259, 381012
HK	Department of Health Drug Office	63303, 66141, 66833
IE	Health Products Regulatory Authority	88874, 89024, 89036
IL	מִשְׂרַד הַבְּרִיאוּת	7422, 9288, 9289
IT	Agenzia del Farmaco	045320013, 045320025, 045320037, 045320049, 045320052, 045320064, 045320076, 045320088, 045320090, 045320102, 045320114, 045320126, 045320138, 045320140, 045320153
JP	医薬品医療機器総合機構	3999034F1020
LT	Valstybinė vaistų kontrolės tarnyba	1082650, 1082651, 1082652, 1085098, 1086551, 1086552, 1086553, 1086554, 1086555, 1086556, 1089144, 1089145, 1089146, 1089147, 1093294
NG	Registered Drug Product Database	B4-7139
Switch country to Nigeria in order to find specific presentations of XELJANZ
NL	Z-Index G-Standaard, PRK	142468, 151998, 201502
PL	Rejestru Produktów Leczniczych	100386232, 100411964, 100413153, 100433820
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65118001, W66577001, W66577002, W68697001
SG	Health Sciences Authority	14664P
TN	Direction de la Pharmacie et du Médicament	20473011
TR	İlaç ve Tıbbi Cihaz Kurumu	8681308031044, 8681308090003
US	FDA, National Drug Code	0069-0501, 0069-0502, 0069-1001, 0069-1002, 63539-012, 63539-016, 63539-501, 63539-502
ZA	Health Products Regulatory Authority	47/3.1/1156