European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

standard diagnostics, inc, korea - sd bioline tb ag mpt64 rapid -

European Union - English - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

Israel - English - Ministry of Health

medison pharma ltd - mecasermin - solution for injection - mecasermin 10 mg / 1 ml - mecasermin - for the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (primary igfd).severe primary igfd is defined by:* height standard deviation score ≤–3.0and* basal igf-1 levels below the 2.5th percentile for age and genderand* gh sufficiency.* exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signaling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment.in some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an igf-i generation test.

Philippines - English - FDA (Food And Drug Administration)

getz pharma (phils.) inc.; distributor: getz pharma (phils.) inc. - levofloxacin (as hemihydrate) - solution for iv infusion - 5mg/ml (750mg/150ml)

Philippines - English - FDA (Food And Drug Administration)

getz pharma (phils.) inc.; distributor: getz pharma (phils.) inc. - levofloxacin (as hemihydrate) - solution for iv infusion - 5mg/ml

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

teva pharmaceuticals usa, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine tablets in hospitali

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

sun pharmaceutical industries, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of 

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

teva pharmaceuticals usa, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the efficacy of venla

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

denton pharma, inc. dba northwind pharmaceuticals - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 10 mg - carefully consider the potential benefits and risks of ketorolac tromethamine tablets usp and other treatment options before deciding to use ketorolac tromethamine tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administrati