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.

Israel - English - Ministry of Health

medison pharma ltd - lanreotide as acetate - solution for injection - lanreotide as acetate 60 mg/dose - lanreotide - lanreotide - somatuline autogel is indicated for the treatment of individuals with acromegaly when the circulating levels of growth hormone (gh) and/or insulin like growth factor-1 (igf-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatmfent .the goal of treatment in acromegaly is to reduce gh and igf-1 levels and where possible to normalize these values. somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (gep-nets) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.

Israel - English - Ministry of Health

medison pharma ltd - lanreotide as acetate - solution for injection - lanreotide as acetate 90 mg/dose - lanreotide - lanreotide - somatuline autogel is indicated for the treatment of individuals with acromegaly when the circulating levels of growth hormone (gh) and/or insulin like growth factor-1 (igf-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatmfent .the goal of treatment in acromegaly is to reduce gh and igf-1 levels and where possible to normalize these values. somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (gep-nets) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.

Israel - English - Ministry of Health

medison pharma ltd - lanreotide as acetate - solution for injection - lanreotide as acetate 120 mg/dose - lanreotide - lanreotide - somatuline autogel is indicated for the treatment of individuals with acromegaly when the circulating levels of growth hormone (gh) and/or insulin like growth factor-1 (igf-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatmfent .the goal of treatment in acromegaly is to reduce gh and igf-1 levels and where possible to normalize these values. somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (gep-nets) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.

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.

United States - English - NLM (National Library of Medicine)

eli lilly and company - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 5 ml - humatrope is indicated for the treatment of pediatric patients with: - growth failure due to inadequate secretion of endogenous growth hormone (gh), - short stature associated with turner syndrome, - idiopathic short stature (iss), height standard deviation score (sds) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, - short stature or growth failure in short stature homeobox-containing gene (shox) deficiency, - short stature born small for gestational age (sga) with no catch-up growth by 2 years to 4 years of age. humatrope is indicated for the replacement of endogenous gh in adults with gh deficiency. humatrope is contraindicated in patients with: - acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see warnings and precautions (5.1)] . - pediatri

United States - English - NLM (National Library of Medicine)

sandoz inc - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - omnitrope (somatropin) injection is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). omnitrope (somatropin) injection is indicated for the treatment of pediatric patients who have growth failure due to prader-willi syndrome (pws). the diagnosis of pws should be confirmed by appropriate genetic testing [see contraindications (4) and warnings and precautions (5.2)] . omnitrope (somatropin) injection is indicated for the treatment of growth failure in children born small for gestational age (sga) who fail to manifest catch-up growth by age 2 years. omnitrope (somatropin) injection is indicated for the treatment of growth failure associated with turner syndrome. omnitrope (somatropin) injection is indicated for the treatment of idiopathic short stature (iss), also called non-growth hormone-deficient short stature, defined by height standard deviation score (sds) ≤ -2.25, and associated with growth rates unlikely to permit attainment of adul

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg in 1.5 ml - norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (gh). norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature associated with noonan syndrome. norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature associated with turner syndrome. norditropin [somatropin (rdna origin) injection] is indicated for the treatment of children with short stature born small for gestational age (sga) with no catch-up growth by age 2-4 years. norditropin [somatropin (rdna origin) injection] is indicated for the replacement of endogenous gh in adults with growth hormone deficiency (ghd) who meet either of the following two criteria: - adult onset (ao): patients who have ghd, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease