Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة ألفه للأدوية - ulfa pharma co. - insulin human 100 iu/ml - 100 iu/ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة ألفه للأدوية - ulfa pharma co. - recombinant human insulin 100 iu/ml - 100 iu/ml

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.

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

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - homatropine hydrobromide 2%;  ; polysorbate 80 0.01% - eye drops, solution - 2 % - active: homatropine hydrobromide 2%   polysorbate 80 0.01% excipient: benzalkonium chloride as 50% solution. hydrochloric acid hypromellose purified water sodium chloride

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - somatropin - powder and solvent for solution for injection - somatropin 10 mg - somatropin - somatropin - children :short stature due to inadequate or failed secretion of pituitary growth hormone or turner's syndrome. short stature in children with renal insufficiency.

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

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: phenol; sucrose; citric acid; poloxamer; water for injections; sodium hydroxide - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).

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

merck healthcare pty ltd - somatropin, quantity: 8 mg/ml - injection, solution - excipient ingredients: sucrose; poloxamer; sodium hydroxide; water for injections; citric acid; phenol - saizen is indicated for:,1. treatment of growth failure in children due to human growth hormone deficiency.,2. treatment of growth failure in girls with gonadal dysgenesis (turner syndrome), confirmed by chromosomal analysis.,3. replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in 2 different dynamic tests for growth hormone deficiency and defind by peak gh concentrations of less than 2.5 nanogram/ml. adults must also fulfill the following criteria: childhood onset: patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with saizen is started. adult onset: patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.,4. treatment of growth disturbance (growth retardation) in pre-pubertal children due to chronic renal insufficiency (cri).