Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 15 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not narmalize igf-i concentrations or was not tolerated.

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - pegvisomant - powder and solvent for solution for injection - pegvisomant 20 mg - pegvisomant - pegvisomant - treatment of adult patient with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not narmalize igf-i concentrations or was not tolerated.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - somatropin - turner syndrome; prader-willi syndrome; dwarfism, pituitary - pituitary and hypothalamic hormones and analogues - infants, children and adolescentsgrowth disturbance due to insufficient secretion of growth hormone (gh).growth disturbance associated with turner syndrome.growth disturbance associated with chronic renal insufficiency.growth disturbance (current height standard-deviation score (sds) < -2.5 and parental adjusted sds < -1) in short children / adolescents born small for gestational age (sga), with a birth weight and / or length below -2 standard deviations (sds), who failed to show catch-up growth (height velocity (hv) sds < 0 during the last year) by four years of age or later.prader-willi syndrome (pws), for improvement of growth and body composition. the diagnosis of pws should be confirmed by appropriate genetic testing.adultsreplacement therapy in adults with pronounced growth hormone deficiency. patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. in patients with childhood-onset isolated gh deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (sds < -2) who may be considered for one test. the cut-off point of the dynamic test should be strict.

European Union - English - EMA (European Medicines Agency)

biopartners gmbh - somatropin - growth - pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists - somatropin biopartners is indicated for the replacement therapy of endogenous growth hormone in adults with childhood- or adult-onset growth-hormone deficiency (ghd).adult-onset: patients with ghd in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone excluding prolactin. these patients should undergo a single dynamic test in order to diagnose or exclude a ghd.childhood-onset: in patients with childhood-onset isolated ghd (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be performed after completion of growth, except for those having low insulin-like-growth-factor-i (igf-i) concentrations (< -2 standard-deviation score (sds)), who may be considered for one test. the cut-off point of the dynamic test should be strict.

European Union - English - EMA (European Medicines Agency)

pfizer europe ma eeig - pegvisomant - acromegaly - pituitary and hypothalamic hormones and analogues - treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf-i concentrations or was not tolerated.treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize igf -i concentrations or was not tolerated.

Australia - English - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - somatropin, quantity: 5 mg/ml - injection, solution - excipient ingredients: water for injections; phenol; polysorbate 20; sodium citrate dihydrate; citric acid; sodium chloride - long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. long-term treatment of growth failure associated with turner syndrome. treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 ng/ml.

Australia - English - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - lanreotide acetate, quantity: 149.4 mg (equivalent: lanreotide, qty 125.5 mg) - injection, solution - excipient ingredients: glacial acetic acid; water for injections - somatuline autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - lanreotide acetate, quantity: 113.6 mg (equivalent: lanreotide, qty 95.4 mg) - injection, solution - excipient ingredients: glacial acetic acid; water for injections - somatuline autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - lanreotide acetate, quantity: 77.9 mg (equivalent: lanreotide, qty 65.4 mg) - injection, solution - excipient ingredients: water for injections; glacial acetic acid - somatuline autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and igf-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (gep-nets) in adult patients with unresectable locally advanced or metastatic disease.

Singapore - English - HSA (Health Sciences Authority)

all eights (singapore) private limited - immunology - the ids-isys insulin-like growth factor-i (igf-i) assay is an in vitro diagnostic device intended for the quantitative determination of igf-i in human serum or plasma on the ids-isys multi-discipline automated system. results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of growth disorders