JAKAVI

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

Active ingredients

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

1 Ruxolitinib
UNII 436LRU32H5 - RUXOLITINIB PHOSPHATE

Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively). These mediate the signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. Ruxolitinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from healthy subjects, MF patients and PV patients.

Read about Ruxolitinib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
JAKAVI Tablet 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
L01EJ01 Ruxolitinib L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EJ Janus-associated kinase (JAK) inhibitors
Discover more medicines within L01EJ01

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): 10614P, 10615Q, 10616R, 10617T, 10618W, 10619X, 10913J, 10927D
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 526516020085601, 526516020085701, 526516020085801, 526520070095707
Country: CA Health Products and Food Branch Identifier(s): 02388006, 02388014, 02388022, 02434814
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 1130-MEE-0715, H45110513, H45130513, H5120513
Country: EE Ravimiamet Identifier(s): 1593020, 1593042, 1593053, 1632800, 1632877, 1632888, 1632899, 1632901, 1632912, 1632923, 1632934, 1632945, 1666010, 1666021, 1666032, 1666043
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 112773005, 112773008, 112773011, 112773015
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 106390, 461113, 488468, 553720
Country: FR Base de données publique des médicaments Identifier(s): 60672974, 65291824, 65584250, 66180136
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 229518, 229748, 229750, 295076
Country: HK Department of Health Drug Office Identifier(s): 61972, 61973, 61974, 66148
Country: IE Health Products Regulatory Authority Identifier(s): 88170, 88182, 88279, 88289
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 7170, 7171, 7172, 8088
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291034F1029, 4291034F2025
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1071542, 1071543, 1071544, 1071545, 1071546, 1071547, 1071548, 1071549, 1071550, 1076654, 1076655, 1076656
Country: NL Z-Index G-Standaard, PRK Identifier(s): 108464, 108472, 108480, 150843
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 16260, 16261, 16262, 19243
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100283673, 100283680, 100283696, 100329688
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W64593001, W64594001, W64595001, W64596001
Country: SG Health Sciences Authority Identifier(s): 14396P, 14397P, 14398P, 14927P
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 10283361H, 10283362H, 10283363H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699504012231, 8699504012248, 8699504012255, 8699504012262, 8699504013177, 8699504013184, 8699504013191, 8699504013207, 8699504013214, 8699504013221, 8699504013238
Country: ZA Health Products Regulatory Authority Identifier(s): 48/34/0109, 48/34/0110, 48/34/0111

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.