STELARA

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

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 about Ustekinumab

Medication package inserts

Below package inserts are available for further reading:

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