以色列 - 英文 - Ministry of Health

novartis israel ltd - octreotide - powder and solvent for suspension for injection - octreotide 10 mg - octreotide - octreotide - treatment of acromegaly in: patients already adequately controlled on standard doses of sandostatin s.c. patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. endocrine gastro-entero- pancreatic (gep) tumors, carcinoid tumors.

以色列 - 英文 - Ministry of Health

novartis israel ltd - basiliximab - powder and solvent for solution for injection/infusion - basiliximab 20 mg/vial - basiliximab - basiliximab - prophylaxis of acute organ rejection in de novo renal transplantation in combination with cyclosporin and corticosteroid based immunosuppression

马来西亚 - 英文 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - diclofenac potassium -

以色列 - 英文 - 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

以色列 - 英文 - Ministry of Health

novartis israel ltd - imatinib as mesylate - film coated tablets - imatinib as mesylate 400 mg - 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.

以色列 - 英文 - 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

以色列 - 英文 - Ministry of Health

novartis israel ltd - secukinumab - solution for injection - secukinumab 150 mg/ml - secukinumab - - plaque psoriasis: cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. - paediatric plaque psoriasis: cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. - psoriatic arthritis: cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (dmard) therapy has been inadequate. - axial spondyloarthritis (axspa) : •ankylosing spondylitis (as, radiographic axial spondyloarthritis) cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. •non-radiographic axial spondyloarthritis (nr-axspa) cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (nsaids). - juvenile idiopathic arthritis (jia) •enthesitis-related arthritis (era) cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitisrelated arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. •juvenile psoriatic arthritis (jpsa) cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy

以色列 - 英文 - Ministry of Health

novartis israel ltd - tisagenlecleucel - dispersion for infusion - tisagenlecleucel - kymriah is indicated for the treatment of: - paediatric and young adult patients up to and including 25 years of age with cd19+ b-cell acute lymphoblastic leukaemia (all) that is refractory, in relapse post-transplant or in second or later relapse. - adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy. limitation of use: kymriah is not indicated for treatment of patients with primary or secondary central nervous system lymphoma- adult patients with relapsed or refractory follicular lymphoma (fl) after two or more lines of systemic therapy

以色列 - 英文 - Ministry of Health

novartis israel ltd - everolimus - tablets dispersible - everolimus 2 mg - everolimus - votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory epileptic seizures are associated with tuberous sclerosis complex (tsc).

以色列 - 英文 - Ministry of Health

novartis israel ltd - everolimus - tablets dispersible - everolimus 3 mg - everolimus - votubia is indicated as adjunctive treatment of patients aged 2 years and older whose refractory epileptic seizures are associated with tuberous sclerosis complex (tsc).