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INREBIC (Bristol-Myers Squibb Australia Pty Ltd)
Product name
INREBIC
Date registered
Evaluation commenced
Decision date
Approval time
215 (255 working days)
Active ingredients
fedratinib hydrochloride
Registration type
NCE/ NBE
Indication
INREBIC is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.