Israël - Engels - 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

Israël - Engels - Ministry of Health

novartis israel ltd - alpelisib - film coated tablets - alpelisib 150 mg - alpelisib - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3camutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Israël - Engels - Ministry of Health

novartis israel ltd - alpelisib - film coated tablets - alpelisib 200 mg - alpelisib - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3camutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Israël - Engels - Ministry of Health

novartis israel ltd - alpelisib - film coated tablets - alpelisib 50 mg - alpelisib - piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative, pik3camutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen

Israël - Engels - Ministry of Health

novartis israel ltd - crizanlizumab - concentrate for solution for infusion - crizanlizumab 10 mg/ml - crizanlizumab - adakveo is indicated to reduce the frequency of vasoocclusive crises (vocs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

Israël - Engels - Ministry of Health

novartis israel ltd - canakinumab - solution for injection - canakinumab 150 mg / 1 ml - canakinumab - ►periodic fever syndromesilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:cryopyrin-associated periodic syndromes (caps)ilaris is indicated for the treatment of cryopyrin-associated periodic syndromes (caps) in adults, adolescents and children aged 2 years and older with body weight of 7.5 kg or above, including:• muckle-wells syndrome (mws),• neonatal-onset multisystem inflammatory disease (nomid) / chronic infantile neurological, cutaneous, articular syndrome (cinca),• severe forms of familial cold autoinflammatory syndrome (fcas) / familial cold urticaria (fcu) presenting with signs and symptoms beyond cold-induced urticarial skin rash.►tumour necrosis factor receptor associated periodic syndrome (traps)ilaris is indicated for the treatment of tumour necrosis factor (tnf) receptor associated periodic syndrome (traps).►hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd)ilaris is indicated for the treatment of hyperimmunoglobulin d syndrome (hids)/ mevalonate kinase deficiency (mkd).►familial mediterranean fever (fmf)ilaris is indicated for the treatment of familial mediterranean fever (fmf) in patients in whom colchicine is contraindicated, is not tolerated, or does not provide an adequate response despite the highest tolerable dose of colchicine.ilaris can be given as monotherapy or in combination with colchicine.ilaris is also indicated for the treatment of:►still’s diseaseilaris is indicated for the treatment of active still’s disease including adult-onset still’s disease (aosd) and systemic juvenile idiopathic arthritis (sjia) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (nsaids) and systemic corticosteroids. ilaris can be given as monotherapy or in combination with methotrexate.►gouty arthritisilaris is indicated for the symptomatic treatment of adult patients with frequent gouty arthritis attacks (at least 3 attacks in the previous 12 months) in whom non-steroidal anti-inflammatory drugs (nsaids) and colchicine are contraindicated, are not tolerated, or do not provide an adequate response, and in whom repeated courses of corticosteroids are not appropriate

Israël - Engels - Ministry of Health

novartis israel ltd - nilotinib as monohydrate - capsules - nilotinib as monohydrate 200 mg - nilotinib - nilotinib - treatment of philadelphia chromosome positive chronic myeloid leukaemia (ph+ cml) in chronic or accelerated phase in patients resistant to or experiencing significant toxicity during treatment with imatinib.treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

Israël - Engels - Ministry of Health

novartis israel ltd - nilotinib as hydrochloride monohydrate - capsules - nilotinib as hydrochloride monohydrate 150 mg - nilotinib - nilotinib - treatment of adult patients with newly diagnosed philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

Israël - Engels - Ministry of Health

novartis israel ltd - omalizumab - powder and solvent for solution for injection - omalizumab 150 mg/dose - omalizumab - omalizumab - allergic asthma xolair is indicated for patients 6 to 12 years of age with severe persistent asthma and for patients 12 years of age and older with moderate to severe persistent asthma, who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. xolair has been shown to decrease the incidence of asthma exacerbations in these patients. limitations of use: xolair is not indicated for the relief of acute bronchospasm or status asthmaticus. xolair is not indicated for the treatment of other allergic conditions.chronic rhinosinusitis with nasal polyps (crswnp) xolair is indicated as an add-on therapy with intranasal corticosteroids (inc) for the treatment of adults (18 years and above) with severe crswnp for whom therapy with inc does not provide adequate disease control.chronic spontaneous urticaria (csu) xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to h1 antihistamine treatment.

Israël - Engels - Ministry of Health

novartis israel ltd - etanercept - solution for injection - etanercept 25 mg / 0.5 ml - etanercept - rheumatoid arthritiserelzi is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (dmards) including methotrexate (unless contraindicated) has been inadequate. erelzi can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis .etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function.juvenile idiopathic arthritistreatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. psoriatic arthritistreatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease.axial spondyloarthritisankylosing spondylitis (as)treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.non-radiographic axial spondyloarthritistreatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (nsaids).plaque psoriasistreatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. paediatric plaque psoriasistreatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.