OLUMIANT

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, Poland, Romania, Singapore, South Africa, Spain, UK.

Active ingredients

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

1
UNII ISP4442I3Y - BARICITINIB
 

Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and >400 nM, respectively. Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.

 
Read more about Baricitinib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 OLUMIANT 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
L04AF02 L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AF Janus-associated kinase (JAK) inhibitors
Discover more medicines within L04AF02

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 11437Y, 11442F, 11443G, 11447L
BR Câmara de Regulação do Mercado de Medicamentos 507619020021501, 507619020021601, 507619020021701, 507619020021801
CA Health Products and Food Branch 02480018
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 4543-MEE-0119, 4806-MEE-0919
EE Ravimiamet 1739189, 1739190, 1739202, 1739213, 1739224, 1739235, 1739246, 1739257, 1739268, 1739279, 1739280, 1739291
ES Centro de información online de medicamentos de la AEMPS 1161170002, 1161170010
FI Lääkealan turvallisuus- ja kehittämiskeskus 407393, 579910
FR Base de données publique des médicaments 61751780, 63788717
GB Medicines & Healthcare Products Regulatory Agency 343458, 346212
HK Department of Health Drug Office 65663, 65664
IE Health Products Regulatory Authority 88875, 88876
IL מִשְׂרַד הַבְּרִיאוּת 8307, 8308
IT Agenzia del Farmaco 045260015, 045260027, 045260039, 045260041, 045260054, 045260066, 045260078, 045260080, 045260092, 045260104, 045260116, 045260128, 045260130, 045260142, 045260155, 045260167, 045260179, 045260181, 045260193
JP 医薬品医療機器総合機構 3999043F1020, 3999043F2026
LT Valstybinė vaistų kontrolės tarnyba 1082320, 1082321, 1082322, 1082323, 1082324, 1082325, 1082326, 1082327, 1082328, 1082329, 1082330, 1082331, 1082332, 1082333, 1082334, 1082335
NL Z-Index G-Standaard, PRK 140848, 140856
PL Rejestru Produktów Leczniczych 100386120, 100386137
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W63493001, W65630001
SG Health Sciences Authority 15504P, 15505P
US FDA, National Drug Code 0002-4182, 0002-4732
ZA Health Products Regulatory Authority 52/3.1/0229, 52/3.1/0230

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