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.

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

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

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

ipsen ltd - cabozantinib s-malate - tablet - 40mg

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

ipsen ltd - cabozantinib s-malate - tablet - 60mg

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 - telotristat ethyl - tablet - 250mg

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.

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