Israel - Inggeris - 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.

Israel - Inggeris - Ministry of Health

novartis israel ltd - ranibizumab - solution for injection - ranibizumab 10 mg/ml - ranibizumab - ranibizumab - treatment of patients with neovascular (wet) age-related macular degeneration (amd). treatment of adult patients with visual impairment due to diabetic macular oedema (dme) . the treatment of visual impairement due to macular oedema secondary to retinal vein occlusion (rvo). the treatment of visual impaiment due to choroidal neovascularization (cnv) . lucentis is indicated in preterm infants for: the treatment of retinopathy of prematurity (rop) with zone i (stage 1+, 2+, 3 or 3+), zone ii (stage 3+) or ap-rop (aggressive posterior rop) disease.the treatment of proliferative diabetic retinopathy (pdr)

Singapura - Inggeris - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - nateglinide - tablet, film coated - 60 mg - nateglinide 60 mg

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - sacubitril/valsartan 50mg (as sodium hydrate complex, contains 24.3 mg sacubitril and 25.7 mg valsartan);  ;   - film coated tablet - 24.3 mg/25.7 mg - active: sacubitril/valsartan 50mg (as sodium hydrate complex, contains 24.3 mg sacubitril and 25.7 mg valsartan)     excipient: colloidal silicon dioxide crospovidone hyprolose basic coating premix, white basic coating premix, red basic coating premix, black magnesium stearate microcrystalline cellulose purified talc purified water - entresto is indicated in adult patients with chronic heart failure (nyha class ii-iv). benefits are most clearly evident in patients with left ventricular ejection fraction (lvef) below normal. lvef is a variable measure, so use clinical judgment in deciding whom to treat

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - sacubitril/valsartan 100mg (as sodium hydrate complex, contains 48.6 mg sacubitril and 51.4 mg valsartan);  ;   - film coated tablet - 48.6 mg/51.4 mg - active: sacubitril/valsartan 100mg (as sodium hydrate complex, contains 48.6 mg sacubitril and 51.4 mg valsartan)     excipient: colloidal silicon dioxide crospovidone hyprolose basic coating premix, white basic coating premix, yellow basic coating premix, red magnesium stearate microcrystalline cellulose purified talc purified water - entresto is indicated in adult patients with chronic heart failure (nyha class ii-iv). benefits are most clearly evident in patients with left ventricular ejection fraction (lvef) below normal. lvef is a variable measure, so use clinical judgment in deciding whom to treat

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - sacubitril/valsartan 200mg (as sodium hydrate complex, contains 97.2 mg sacubitril and 102.8 mg valsartan);  ;   - film coated tablet - 97.2 mg/102.8 mg - active: sacubitril/valsartan 200mg (as sodium hydrate complex, contains 97.2 mg sacubitril and 102.8 mg valsartan)     excipient: colloidal silicon dioxide crospovidone hyprolose basic coating mixture, white basic coating mixture, red basic coating mixture, black magnesium stearate microcrystalline cellulose purified talc purified water - entresto is indicated in adult patients with chronic heart failure (nyha class ii-iv). benefits are most clearly evident in patients with left ventricular ejection fraction (lvef) below normal. lvef is a variable measure, so use clinical judgment in deciding whom to treat

Israel - Inggeris - 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 - Inggeris - Ministry of Health

novartis israel ltd - mycophenolic acid - gastro resistant tablets - mycophenolic acid 180 mg - mycophenolic acid - myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.

Israel - Inggeris - Ministry of Health

novartis israel ltd - mycophenolic acid - gastro resistant tablets - mycophenolic acid 360 mg - mycophenolic acid - myfortic is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants.

Israel - Inggeris - 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).