Israel - English - Ministry of Health

novartis israel ltd - ruxolitinib as phosphate - tablets - ruxolitinib as phosphate 5 mg - ruxolitinib - ruxolitinib - * * myelofibrosis (mf) jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. * polycythaemia vera (pv) jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.*graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies

Israel - English - Ministry of Health

novartis israel ltd - ruxolitinib as phosphate - tablets - ruxolitinib as phosphate 15 mg - ruxolitinib - ruxolitinib - * myelofibrosis (mf) jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. * polycythaemia vera (pv) jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.*graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies

Israel - English - Ministry of Health

novartis israel ltd - ruxolitinib as phosphate - tablets - ruxolitinib as phosphate 20 mg - ruxolitinib - ruxolitinib - * myelofibrosis (mf) jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. * polycythaemia vera (pv) jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.*graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 13.2 mg (equivalent: ruxolitinib, qty 10 mg) - tablet - excipient ingredients: hyprolose; povidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 19.8 mg (equivalent: ruxolitinib, qty 15 mg) - tablet - excipient ingredients: povidone; microcrystalline cellulose; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; colloidal anhydrous silica - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 6.6 mg (equivalent: ruxolitinib, qty 5 mg) - tablet - excipient ingredients: hyprolose; povidone; lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; sodium starch glycollate type a - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ruxolitinib phosphate, quantity: 26.4 mg (equivalent: ruxolitinib, qty 20 mg) - tablet - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; hyprolose; magnesium stearate; lactose monohydrate; sodium starch glycollate type a; povidone - jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis.,jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.,jakavi is indicated for the treatment of patients aged 12 years and older with acute graft-versus-host disease who have inadequate response to corticosteroids.,jakavi is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease who have inadequate response to corticosteroids.

Israel - English - Ministry of Health

novartis israel ltd - ruxolitinib as phosphate - tablets - ruxolitinib as phosphate 10 mg - ruxolitinib - * myelofibrosis (mf) jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. * polycythaemia vera (pv) jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.*graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (as phosphate) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastic agents - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.polycythaemia vera (pv)jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).

United States - English - NLM (National Library of Medicine)

incyte corporation - ruxolitinib (unii: 82s8x8xx8h) (ruxolitinib - unii:82s8x8xx8h) - ruxolitinib 5.0 mg - jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (mf), including primary mf, post-polycythemia vera mf and post-essential thrombocythemia mf in adults. jakafi is indicated for treatment of polycythemia vera (pv) in adults who have had an inadequate response to or are intolerant of hydroxyurea. jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (agvhd) in adult and pediatric patients 12 years and older. jakafi is indicated for treatment of chronic graft-versus-host disease (cgvhd) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. none. risk summary when pregnant rats and rabbits were administered ruxolitinib during the period of organogenesis adverse developmental outcomes occurred at doses associated with maternal toxicity (see data ). there are no studies with the use of jakafi in pregnant women to inform drug-associated risks. the background risk of major birth defects and miscarriage for