RINVOQ

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

Active ingredients

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

1
UNII NEW4DV02U5 - UPADACITINIB HEMIHYDRATE
 

Upadacitinib is a selective and reversible Janus kinase (JAK) inhibitor. In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell maturation and JAK3 signals play a role in immune surveillance and lymphocyte function.

 
Read more about Upadacitinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 RINVOQ Extended-release tablet MPI, US: SPL/PLR FDA, National Drug Code (US)
 RINVOQ Prolonged-release 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
L04AF03 L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AF Janus-associated kinase (JAK) inhibitors
Discover more medicines within L04AF03

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 11979L, 11989B
BR Câmara de Regulação do Mercado de Medicamentos 543720060004207, 543720060004307
CA Health Products and Food Branch 02495155
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 5591-MEE-1020, 7080-MEE-0322
EE Ravimiamet 1808951, 1808962, 1808973, 1809312, 1809323, 1860588, 1860601, 1860612, 1860623, 1887857, 1887891
ES Centro de información online de medicamentos de la AEMPS 1191404001
FI Lääkealan turvallisuus- ja kehittämiskeskus 091893
FR Base de données publique des médicaments 65852428
GB Medicines & Healthcare Products Regulatory Agency 380675
HK Department of Health Drug Office 66872
IE Health Products Regulatory Authority 89057, 89155
IL מִשְׂרַד הַבְּרִיאוּת 8740, 9072, 9307
IT Agenzia del Farmaco 048399012, 048399024, 048399036, 048399048, 048399051, 048399063, 048399075, 048399087, 048399099, 048399101, 048399113
JP 医薬品医療機器総合機構 3999048G1028, 3999048G2024, 3999048G3020, 3999048G4027
LT Valstybinė vaistų kontrolės tarnyba 1089080, 1089081, 1089082, 1089083, 1089084, 1093301, 1093302, 1093303, 1093304
NL Z-Index G-Standaard, PRK 201073
NZ Medicines and Medical Devices Safety Authority 20573, 22034
PL Rejestru Produktów Leczniczych 100427770
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W66589001, W68028001, W69486001, W69486002
TR İlaç ve Tıbbi Cihaz Kurumu 8680656080575, 8680656080582
US FDA, National Drug Code 0074-2306
ZA Health Products Regulatory Authority 54/3.1/0187

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