Israel - Inggeris - Ministry of Health

takeda israel ltd - human normal immunoglobulin - solution for infusion - human normal immunoglobulin 100 mg / 1 ml - immunoglobulins, normal human, for intravascular adm. - replacement therapy in adults, children and adolescents (0-18 years) in:• primary immunodeficiency syndromes with impaired antibody production • hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cll), in whom prophylactic antibiotics have failed or are contra-indicated.• hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (mm) patients.• hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (hsct).

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon 8 mg - rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with rozerem should not be rechallenged with the drug. patients should not take rozerem in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with rozerem use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

Israel - Inggeris - Ministry of Health

takeda israel ltd - lanadelumab - solution for injection - lanadelumab 150 mg/ml - lanadelumab - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae)in patients aged 2 years and older.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - alogliptin 12.5 mg - kazano is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use kazano is not recommended for use in patients with type 1 diabetes mellitus. kazano is contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2 ) [see warnings and precautions (5.1)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. - history of serious hypersensitivity reaction to alogliptin or metformin or any of the excipients in kazano, such as anaphylaxis, angioedema and severe cutaneous adverse reactions [see warnings and precautions (5.4), adverse reactions (6.2)]. risk summary limited available data with kazano or alogliptin in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [se

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86) - alogliptin 6.25 mg - nesina is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use nesina is not recommended for use in patients with type 1 diabetes mellitus. nesina is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in nesina. reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see warnings and precautions (5.3), adverse reactions (6.2)] . risk summary limited data with nesina in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations] . no adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180- and 149-times the 25 mg clinical dose, respectively, based on plasma drug

Malaysia - Inggeris - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - vonoprazan fumarate -

Malaysia - Inggeris - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - vonoprazan fumarate -

Israel - Inggeris - Ministry of Health

takeda israel ltd - vedolizumab - powder for concentrate for solution for infusion - vedolizumab 300 mg/vial - vedolizumab - ulcerative colitis:entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.crohn’s disease:entyvio is indicated for the treatment of adult patients with moderately to severely active crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (tnfα) antagonist.

Israel - Inggeris - Ministry of Health

takeda israel ltd - factor viii inhibitor bypassing fraction - powder and solvent for solution for injection/infusion - factor viii inhibitor bypassing fraction 1000 u/vial - factor viii inhibitor bypassing activity - factor viii inhibitor bypassing activity - control of bleeding episodes in haemophilia a patients with factor viii inhibitors and also in patients with acquired factor viii inhibitors .control of bleeding in hemophilia b patients with inhibitors, if no other specific treatment is available.

Singapura - Inggeris - HSA (Health Sciences Authority)

takeda pharmaceuticals (asia pacific) pte. ltd. - policresulen - suppository - 90 mg - policresulen 90 mg