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.

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.

European Union - English - EMA (European Medicines Agency)

ipsen pharma - cabozantinib (s)-malate - carcinoma, renal cell; carcinomas, hepatocellular - antineoplastic agents - renal cell carcinoma (rcc)cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (rcc):in treatment-naïve adults with intermediate or poor risk,in adults following prior vascular endothelial growth factor (vegf)-targeted therapy.cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.hepatocellular carcinoma (hcc)cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (hcc) in adults who have previously been treated with sorafenib.

European Union - English - EMA (European Medicines Agency)

ipsen pharma - cabozantinib - thyroid neoplasms - antineoplastic agents - treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.

European Union - English - EMA (European Medicines Agency)

ipsen pharma - somatropin - turner syndrome; dwarfism, pituitary - pituitary and hypothalamic hormones and analogues - 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.replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. growth hormone deficiency should be confirmed appropriately prior to treatment.

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

teva pharmaceuticals usa, inc. - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - desogestrel 0.15 mg - reclipsen™ (desogestrel and ethinyl estradiol tablets usp) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with reclipsen (desogestrel and ethinyl estradiol tablets usp), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. table 1: percentage of women experiencing an unintended pregnancy during the first year of typi

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

rpk pharmaceuticals, inc. - desogestrel (unii: 81k9v7m3a3) (desogestrel - unii:81k9v7m3a3), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - reclipsen™ (desogestrel and ethinyl estradiol tablets usp) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and the norplant system depends upon the reliability with which they are used. correct and consistent use of these methods can result in lower failure rates. in a clinical trial with reclipsen (desogestrel and ethinyl estradiol tablets usp), 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. this represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. this rate includes patients who did not take the drug correctly. table 1: percentage of women experiencing an unintended pregnancy during the first year of typi

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ipsen ltd - somatropin (rbe) - solution for injection - 5mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ipsen ltd - mecasermin - solution for injection - 10mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

ipsen ltd - cabozantinib s-malate - tablet - 20mg