STELARA

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, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Ustekinumab UNII FU77B4U5Z0 - USTEKINUMAB
	Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 from binding to the IL-12R1 receptor protein expressed on the surface of immune cells. Abnormal regulation of IL 12 and IL 23 has been associated with immune mediated diseases, such as psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
	Read more about Ustekinumab

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
STELARA Solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)
STELARA Concentrate for solution for infusion	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
L04AC05	Ustekinumab	L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AC Interleukin inhibitors
Discover more medicines within L04AC05

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	10767Q, 10774C, 11164N, 11178H, 11182M, 9304Q, 9305R
BR	Câmara de Regulação do Mercado de Medicamentos	514507901152211, 514515100027903, 514515100028003, 514517100034103
CA	Health Products and Food Branch	02320673, 02320681, 02459671
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	213-MBE-0821, 82-MBE-1216
EE	Ravimiamet	1399181, 1399192, 1462395, 1462407, 1735613
ES	Centro de información online de medicamentos de la AEMPS	08494001, 08494003, 108494004, 108494005
FI	Lääkealan turvallisuus- ja kehittämiskeskus	033918, 093827, 093838, 184205
FR	Base de données publique des médicaments	65283311, 66170398, 67522169, 69340343
GB	Medicines & Healthcare Products Regulatory Agency	151171, 174628, 308164, 337496
HK	Department of Health Drug Office	60837, 60838, 62386, 62387, 65510
IE	Health Products Regulatory Authority	88521, 88522, 88525
IL	מִשְׂרַד הַבְּרִיאוּת	6418, 7301, 7302, 8002
IT	Agenzia del Farmaco	038936011, 038936023, 038936035, 038936047, 038936050, 038936062, 038936074
JP	医薬品医療機器総合機構	3999431A1022, 3999431G1025
LT	Valstybinė vaistų kontrolės tarnyba	1036003, 1036004, 1063653, 1063654, 1082209
NL	Z-Index G-Standaard, PRK	100293, 102989, 122017, 138247
NZ	Medicines and Medical Devices Safety Authority	14151, 14152, 18261
PL	Rejestru Produktów Leczniczych	100201758, 100201764, 100230808, 100230814, 100380940
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W53884001, W53885001, W64275001, W64276001
SG	Health Sciences Authority	13704P, 13705P, 13995P, 13996P, 15438P
TN	Direction de la Pharmacie et du Médicament	15273041H, 15273042H, 15273043H, 15273044H
TR	İlaç ve Tıbbi Cihaz Kurumu	8699593760044, 8699593775109, 8699593950018, 8699593950025
US	FDA, National Drug Code	57894-054, 57894-060, 57894-061
ZA	Health Products Regulatory Authority	43/30.2/0727, 43/30.2/0728, 51/30.1/0851