New Zealand - English - 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 - English - 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 - English - 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 - English - 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 - English - 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 - English - 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).

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

novartis south africa (pty) ltd - diluent for injection - see ingredients - each ampoule contains water for injections 5ml or 10 ml

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

novartis south africa (pty) ltd - eyedrops - see ingredients - each 1,0 ml suspension contains nepafenac 1,0 mg

Germany - English - HMA (Heads of Medicines Agencies)

novartis sa - milbemycin a<3>-oxim 2.5 mg, praziquantel 25 mg - chewable tablet - dogs - milbemycin, combinations

Austria - English - HMA (Heads of Medicines Agencies)

novartis sa - milbemycin a<3>-oxim 2.5 mg, praziquantel 25 mg - chewable tablet - dogs - milbemycin, combinations