Israel - engleză - Ministry of Health

novartis israel ltd - etanercept - solution for injection - etanercept 50 mg / 1 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.

Israel - engleză - Ministry of Health

novartis israel ltd - adalimumab - solution for injection - adalimumab 50 mg/ml - adalimumab - rheumatoid arthritis hyrimoz in combination with methotrexate is indicated for:  the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.adalimumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function, when given in combination with methotrexate. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritis:hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (dmards). hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate . adalimumab has not been studied in patients aged less than 2 years. enthesitis-related arthritis:hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapyaxial spondyloarthritisankylosing spondylitis (as): hyrimoz is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as: hyrimoz is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as, but with objective signs of inflammation by radiological and/or laboratory tests including mri and serum crp levels , who have had an inadequate response to, or are intolerant to, non - steroidal anti-inflammatory drugs. psoriatic arthritis hyrimoz is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. psoriasis hyrimoz is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.hidradenitis suppurativa (hs)hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy. crohn’s disease hyrimoz is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active crohn’s disease who have had an inadequate response to conventional therapy. hyrimoz is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.paediatric crohn's disease hyrimoz is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6- years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies ulcerative colitis hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.paediatric ulcerative colitis hyrimoz is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies.uveitis hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.paediatric uveitis hyrimoz is indicated for the treatment of chronic non-infectious uveitis in paediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.intestinal behcet’s diseasehyrimoz is indicated for the treatment of intestinal behcet’s disease in patients who have had an inadequate response to conventional therapy.

Israel - engleză - 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 - engleză - 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 - engleză - 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

Israel - engleză - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 100 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist).glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy.* adult patients with relapsed or refractory ph + all as monotherapy.* adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration fo chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation.* adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - engleză - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - imatinib - imatinib - glivec is indicated for the treatment of adult patients and children 3 years of age and above with ph+ chronic myeloid leukaemia (ph+ -cml) in chronic phase accelerated phase or blast crisis. glivec is also indicated for the treatment of adult patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). glivec is also indicated for the treament of : * adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) integrated with chemotherapy. * adult patients with relapsed or refractory ph + all as monotherapy. * adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. * adult patients with myelodyspiastic/myeloproliferative diseases (mds/mpd) associated with pdgfr (platelet - derived growth factor receptor ) gene re- arrangements. * adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) who have the fip1l1- pdgfralfa fusion kinase (mutational analysis or fish demonstration for chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfr alfa fusion kinase negative. * adult patients with aggressive systemic mastocytosis (asm) without the d816v c-kit mutation. * adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist.

Israel - engleză - Ministry of Health

novartis israel ltd - ceritinib - hard gelatin capsules - ceritinib 150 mg - ceritinib - zykadia is indicated for the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive.23.04.2018 בקשה לשינוי משטר מינון - dose modification for patients with severe hepatic impairment (child-pugh c), reduce the dose of zykadia by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength- new starting dose - 450 mg taken orally once daily with food (instead of 750mg taken on empty stomach).first dose reduction due to adverse reactions- 300 mg taken orally once daily with food, second dose reduction - 150 mg taken orally once daily with food. discontinue zykadia for patients unable to tolerate 150 mg daily with food.

Israel - engleză - Ministry of Health

novartis israel ltd - glycopyrronium as bromide - inhalation powder hard capsules - glycopyrronium as bromide 50 mcg - glycopyrronium - maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).

Israel - engleză - Ministry of Health

novartis israel ltd - brimonidine tartrate; brinzolamide - eye drops suspension - brimonidine tartrate 2 mg / 1 ml; brinzolamide 10 mg / 1 ml - brinzolamide, combinations - decrease of elevated intraocular pressure (iop) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient iop reduction.