欧盟 - 英文 - EMA (European Medicines Agency)

n.v. organon - nomegestrol acetate, estradiol - contraception - sex hormones and modulators of the genital system, - oral contraception.

欧盟 - 英文 - EMA (European Medicines Agency)

theramex ireland limited - nomegestrol acetate, estradiol - contraception - sex hormones and modulators of the genital system, - oral contraception,

欧盟 - 英文 - EMA (European Medicines Agency)

abbvie ltd - ombitasvir / paritaprevir / ritonavir - hepatitis c, chronic - antivirals for systemic use - viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults.

美国 - 英文 - NLM (National Library of Medicine)

celgene corporation - enasidenib mesylate (unii: uf6pc17xav) (enasidenib - unii:3t1ss4e7ag) - enasidenib mesylate 50 mg - idhifa is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (aml) with an isocitrate dehydrogenase-2 (idh2) mutation as detected by an fda-approved test. none. based on animal embryo-fetal toxicity studies, idhifa can cause fetal harm when administered to a pregnant woman. there are no available data on idhifa use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. in animal embryo-fetal toxicity studies, oral administration of enasidenib to pregnant rats and rabbits during organogenesis was associated with embryo-fetal mortality and alterations to growth starting at 0.1 times the steady state clinical exposure based on the auc at the recommended human dose (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. enasidenib administered to pregnant rats at a dose of 30 mg/kg twice daily during organogenesis (gestation days 6-17) was associated with maternal toxicity and adverse embryo-fetal effects including post-implantation loss, resorptions, decreased viable fetuses, lower fetal birth weights, and skeletal variations. these effects occurred in rats at approximately 1.6 times the clinical exposure at the recommended human daily dose of 100 mg/day. in pregnant rabbits treated during organogenesis (gestation days 7-19), enasidenib was maternally toxic at doses equal to 5 mg/kg/day or higher (exposure approximately 0.1 to 0.6 times the steady state clinical exposure at the recommended daily dose) and caused spontaneous abortions at 5 mg/kg/day (exposure approximately 0.1 times the steady state clinical exposure at the recommended daily dose). risk summary there are no data on the presence of enasidenib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with idhifa and for 2 months after the last dose. based on animal embryo-fetal toxicity studies, idhifa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . verify pregnancy status in females of reproductive potential prior to starting idhifa. advise females of reproductive potential to use effective contraception during treatment with idhifa and for 2 months after the last dose. coadministration of idhifa may decrease the concentrations of combined hormonal contraceptives. advise patients using hormonal contraceptives to use an effective non-hormonal contraceptive method during treatment with idhifa and for 2 months after the last dose [see drug interactions (7.1)] . advise males with female partners of reproductive potential to use effective contraception during treatment with idhifa and for 2 months after the last dose of idhifa. based on findings in animals, idhifa may impair fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see nonclinical toxicology (13.1)] . safety and effectiveness of idhifa in pediatric patients have not been established. no dosage adjustment is required for idhifa based on age. in the clinical study, 61% of 214 patients were aged 65 years or older, while 24% were older than 75 years. no overall differences in effectiveness or safety were observed between patients aged 65 years or older and younger patients.

美国 - 英文 - NLM (National Library of Medicine)

corcept therapeutics incorporated - mifepristone (unii: 320t6rnw1f) (mifepristone - unii:320t6rnw1f) - mifepristone 300 mg - korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. limitations of use: - korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to cushing's syndrome. korlym is contraindicated in: - pregnancy [see dosage and administration (2.1), use in specific populations (8.1,8.3)] - patients taking drugs metabolized by cyp3a such as simvastatin, lovastatin, and cyp3a substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus, due to an increased risk of adverse events. [see drug interactions (7.1) and clinical pharmacology (12.3)] - patients receiving systemic corticosteroids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because korlym antagonizes the effect of glucocorticoids. - women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma. - patients with known hypersensitivity to mifepristone or to any of the product components. risk summary korlym is contraindicated in pregnancy because the use of korlym results in pregnancy loss. there are no data that assess the risk of birth defects in women exposed to korlym during pregnancy. available data limited to exposure following a single dose of mifepristone during pregnancy showed a higher rate of major birth defects compared to the general population comparator (see data) . mifepristone administered to pregnant mice, rats, and rabbits during organogenesis caused pregnancy loss in all species at clinically relevant doses based on body surface area comparisons (see data) . the inhibition of both endogenous and exogenous progesterone by mifepristone at the progesterone receptor results in pregnancy loss. if korlym is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. [see contraindications (4)] the estimated risk of fetal loss is elevated in patients with active cushing's syndrome (24-30%), and the risk of major birth defects is unknown. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. data human data there are no data on long term exposure to mifepristone in pregnancy. available data are limited to exposure to a single dose of mifepristone for pregnancy termination. in a prospective study in france of 46 pregnancies exposed to a single dose of mifepristone alone and 59 pregnancies exposed to a single dose of mifepristone and misoprostol, the overall major birth defect rate (4%) was greater than the general population background rate of 2 to 3% (2 birth defects in each group). there was no pattern of birth defects identified. animal data reproductive studies were performed in mice, rats and rabbits at doses of 0.25 to 4.0 mg/kg (less than human exposure at the maximum clinical dose, based on body surface area). because of the anti-progestational activity of mifepristone, fetal losses were much higher than in control animals. skull deformities were detected in rabbit studies at less than human exposure, although mifepristone did not cause any adverse developmental effects in rats or mice during organogenesis. these deformities were most likely due to the mechanical effects of uterine contractions resulting from antagonism of the progesterone receptor. risk summary mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for korlym and any potential adverse effects on the breastfed child from korlym or from the underlying maternal condition. clinical considerations to minimize exposure to a breastfed infant, women who discontinue or interrupt korlym treatment may consider pumping and discarding milk during treatment and for 18-21 days (5-6 half-lives) after the last dose, before breastfeeding. data available published data based on intake of a single dose of 600 mg of mifepristone in 10 breastfeeding women who were 6-12 months postpartum showed a small amount in breast milk (the estimated relative infant dose was 0.5%). the half-life of mifepristone is longer with repeat dosing compared to a single dose; therefore, there may be greater exposure with long term use. pregnancy testing due to its anti-progestational activity, korlym causes pregnancy loss. perform pregnancy testing before the initiation of treatment with korlym or if treatment is interrupted for more than 14 days in females of reproductive potential. contraception recommend non-hormonal contraception for the duration of treatment and for one month after stopping treatment . korlym interferes with the effectiveness of hormonal contraceptives. [see drug interactions (7.6)] safety and effectiveness of korlym in pediatric patients have not been established. clinical studies with korlym did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger people. the maximum dose should not exceed 600 mg per day in renally impaired patients. [see clinical pharmacology (12.3)] in patients with mild to moderate hepatic impairment, the maximum dose should not exceed 600 mg per day. the pharmacokinetics of mifepristone in patients with severe hepatic impairment has not been studied, and korlym should not be used in these patients. [see clinical pharmacology (12.3)]

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - lapatinib ditosilate monohydrate, quantity: 405 mg (equivalent: lapatinib, qty 250 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; sodium starch glycollate type a; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - human epidermal growth factor receptor 2 positive (her2+) over expressing advanced or metastatic breast cancer,tykerb is indicated in combination with:,? an aromatase inhibitor for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) (epidermal growth factor receptor 2) and for whom hormonal therapy is indicated.,? capecitabine for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting.,? paclitaxel for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate (see section 5.1 pharmacodynamic properties - clinical trials). tykerb, in combination with capecitabine, is indicated for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline, a taxane and trastuzumab.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - lapatinib ditosilate monohydrate, quantity: 405 mg (equivalent: lapatinib, qty 250 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; magnesium stearate; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400 - human epidermal growth factor receptor 2 positive (her2+) over expressing advanced or metastatic breast cancer,tykerb is indicated in combination with:,? an aromatase inhibitor for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) (epidermal growth factor receptor 2) and for whom hormonal therapy is indicated.,? capecitabine for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting.,? paclitaxel for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate (see section 5.1 pharmacodynamic properties - clinical trials).

英国 - 英文 - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - tamoxifen citrate - oral tablet - 20mg

英国 - 英文 - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord-uk ltd - tamoxifen citrate - oral tablet - 20mg

英国 - 英文 - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - tamoxifen citrate - oral tablet - 20mg