Summary basis of decision for JAKAVI

Health Canada has issued a Notice of Compliance to Novartis Pharmaceuticals Canada Inc., for the drug product Jakavi. Jakavi contains the medicinal ingredient ruxolitinib, an antineoplastic agent that functions as a Janus Associated Kinase 1 (JAK1) and JAK2 inhibitor. As a JAK inhibitor, ruxolitinib is the first drug in this class of agents to receive marketing authorization in Canada. Jakavi is indicated for the treatment of splenomegaly and/or its associated symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis. Read more here.