OMJJARA (GlaxoSmithKline Australia Pty Ltd)
Product name
OMJJARA
Date registered
Evaluation commenced
Decision date
Approval time
117 (120 working days)
Active ingredients
momelotinib dihydrochloride monohydrate
Registration type
NCE/ NBE
Indication
OMJJARA is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.