European Union - English - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetate - diagnostic techniques, endocrine - macimorelin - this medicinal product is for diagnostic use only. ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

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

arrotex pharmaceuticals pty ltd - macrogol 3350, quantity: 13125 mg; sodium chloride, quantity: 350.7 mg; potassium chloride, quantity: 46.6 mg; sodium bicarbonate, quantity: 178.5 mg - powder, oral - excipient ingredients: acesulfame potassium - for effective relief from constipation, treatment of constipation, and treatment of faecal impaction defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by the physical examination of the abdomen and rectum, in adults and children 12 years and over.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

strides pharma ltd. - macrogol 3350 13125 mg; sodium chloride 350,7 mg; sodium hydrogen carbonate 178,5 mg; potassium chloride 46,6 mg - powder for oral solution - 13.7 g - macrogol 3350 13125 mg; sodium chloride 350.7 mg; sodium bicarbonate 178.5 mg; potassium chloride 46.6 mg - macrogol, combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

strides pharma ltd. - macrogol 3350 6562,5 mg; sodium chloride 175,35 mg; sodium hydrogen carbonate 89,25 mg; potassium chloride 23,3 mg - powder for oral solution - 6,9 g - macrogol 3350 6562.5 mg; sodium chloride 175.35 mg; sodium bicarbonate 89.25 mg; potassium chloride 23.3 mg - macrogol, combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - macrogol 13,125 g; potassium chloride 0,0466 g; sodium hydrogen carbonate 0,1785 g; sodium chloride 0,3507 g - powder for oral solution - 13,7 g - macrogol 3350 13.125 g; sodium chloride 0.351 g; potassium chloride 0.047 g; sodium bicarbonate 0.179 g - macrogol, combinations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - macrogol 4000 mg - powder for oral solution in sachet - 4 g - macrogol 4000 4000 mg - macrogol

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

aurobindo sa-nv - macrogol 10000 mg - powder for oral solution in sachet - 10 g - macrogol 4000 10000 mg - macrogol

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

novartis pharmaceuticals corporation - eltrombopag olamine (unii: 4u07f515lg) (eltrombopag - unii:s56d65xj9g) - eltrombopag 12.5 mg - promacta is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (itp) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. promacta should be used only in patients with itp whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. promacta is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis c to allow the initiation and maintenance of interferon-based therapy. promacta should be used only in patients with chronic hepatitis c whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. - promacta is indicated in combination with standard immunosuppressive therapy (ist) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. - promacta is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. - promacta is not indicated for the treatment of patients with myelodysplastic syndromes (mds) [see warnings and precautions (5.3)] . - safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis c infection. none. risk summary available data from a small number of published case reports and postmarketing experience with promacta use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses. these effects were observed at doses resulting in exposures that were six times the human clinical exposure based on area under the curve (auc) in patients with persistent or chronic itp at 75 mg/day, and three times the auc in patients with chronic hepatitis c at 100 mg/day (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in an early embryonic development study, female rats received oral eltrombopag at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on auc in patients with itp at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). increased pre- and post-implantation loss and reduced fetal weight were observed at the highest dose which also caused maternal toxicity. in an embryo-fetal development study eltrombopag was administered orally to pregnant rats during the period of organogenesis at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on auc in patients with itp at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). decreased fetal weights (6% to 7%) and a slight increase in the presence of cervical ribs were observed at the highest dose which also caused maternal toxicity. however, no evidence of major structural malformations was observed. in an embryo-fetal development study eltrombopag was administered orally to pregnant rabbits during the period of organogenesis at doses of 30, 80, or 150 mg/kg/day (0.04, 0.3, and 0.5 times, respectively, the human clinical exposure based on auc in patients with itp at 75 mg/day and 0.02, 0.1, and 0.3 times, respectively, the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). no evidence of fetotoxicity, embryolethality, or teratogenicity was observed. in a pre- and post-natal developmental toxicity study in pregnant rats (f0), oral eltrombopag was administered from gestation day 6 through lactation day 20. no adverse effects on maternal reproductive function or on the development of the offspring (f1) were observed at doses up to 20 mg/kg/day (2 times the human clinical exposure based on auc in patients with itp at 75 mg/day and similar to the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). eltrombopag was detected in the plasma of offspring (f1). the plasma concentrations in pups increased with dose following administration of drug to the f0 dams. risk summary there are no data regarding the presence of eltrombopag or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. however, eltrombopag was detected in the pups of lactating rats 10 days postpartum suggesting the potential for transfer during lactation. due to the potential for serious adverse reactions in a breastfed child from promacta, breastfeeding is not recommended during treatment. contraception based on animal reproduction studies, promacta can cause fetal harm when administered to a pregnant woman. sexually-active females of reproductive potential should use effective contraception (methods that result in less than 1% pregnancy rates) when using promacta during treatment and for at least 7 days after stopping treatment with promacta. the safety and efficacy of promacta have been established in pediatric patients 1 year and older with persistent or chronic itp and in pediatric patients 2 years and older with ist-naïve severe aplastic anemia (in combination with h-atg and cyclosporine). safety and efficacy in pediatric patients below the age of 1 year with itp have not been established. safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis c and refractory severe aplastic anemia have not been established. the safety and efficacy of promacta in pediatric patients 1 year and older with persistent or chronic itp were evaluated in two double-blind, placebo-controlled trials [see adverse reactions (6.1), clinical studies (14.1)] . the pharmacokinetics of eltrombopag have been evaluated in 168 pediatric patients 1 year and older with itp dosed once daily [see clinical pharmacology (12.3)] . see dosage and administration (2.1) for dosing recommendations for pediatric patients 1 year and older. the safety and efficacy of promacta in combination with h-atg and cyclosporine for the first-line treatment of severe aplastic anemia in pediatric patients 2 years and older were evaluated in a single-arm, open-label trial [see adverse reactions (6.1), clinical studies (14.3)] . a total of 26 pediatric patients (ages 2 to < 17 years) were evaluated; 12 children (aged 2 to < 12 years) and 14 adolescents (aged 12 to < 17). see dosage and administration (2.3) for dosing recommendations for pediatric patients 2 years and older. the safety and efficacy of promacta in combination with h-atg and cyclosporine in pediatric patients younger than 2 years for the first-line treatment of severe aplastic anemia have not yet been established. in patients 2 to 16 years of age, 69% of patients experienced serious adverse events compared to 42% in patients 17 years and older. among the 12 patients who were 2 to 11 years of age in the promacta d1-m6 cohort and reached the 6-month assessment or withdrew earlier, the complete response rate at month 6 was 8% versus 46% in patients age 12 to 16 years and 50% in patients 17 years of age and older. of the 106 patients in two randomized clinical trials of promacta 50 mg in persistent or chronic itp, 22% were 65 years of age and over, while 9% were 75 years of age and over. of the 1439 patients in two randomized clinical trials of promacta in patients with chronic hepatitis c and thrombocytopenia, 7% were 65 years of age and over, while < 1% were 75 years of age and over. of the 196 patients who received promacta for the treatment of severe aplastic anemia, 18% were 65 years of age and over, while 3% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these patients and younger patients. patients with persistent or chronic itp and severe aplastic anemia reduce the initial dose of promacta in patients with persistent or chronic itp (adult and pediatric patients 6 years and older only) or refractory severe aplastic anemia who also have hepatic impairment (child-pugh class a, b, c) [see dosage and administration (2.1, 2.3), warnings and precautions (5.2), clinical pharmacology (12.3)] . in a clinical trial in patients with severe aplastic anemia who had not received prior definitive immunosuppressive therapy, patients with baseline alt or ast > 5 x uln were ineligible to participate. if a patient with hepatic impairment (child-pugh class a, b, c) initiates therapy with promacta for the first-line treatment of severe aplastic anemia, reduce the initial dose [see dosage and administration (2.3), warnings and precautions (5.2), clinical pharmacology (12.3)] . patients with chronic hepatitis c no dosage adjustment is recommended in patients with chronic hepatitis c and hepatic impairment [see clinical pharmacology (12.3)] . reduce the initial dose of promacta for patients of east-/southeast-asian ancestry with itp (adult and pediatric patients 6 years and older only) or severe aplastic anemia [see dosage and administration (2.1, 2.3), clinical pharmacology (12.3)] . no reduction in the initial dose of promacta is recommended in patients of east-/southeast-asian ancestry with chronic hepatitis c [see clinical pharmacology (12.3)] .

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

ferring pharmaceuticals inc. - somatropin (unii: nqx9kb6pcl) (somatropin - unii:nqx9kb6pcl) - somatropin 5 mg - zomacton 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 (hsds) ≤-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. zomacton is indicated for the replacement of endogenous gh in adults with gh deficiency. zomacton 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)] . - pediatric patients with prader-willi s

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

arrotex pharmaceuticals pty ltd - sodium chloride, quantity: 175.35 mg; macrogol 3350, quantity: 6562.5 mg; sodium bicarbonate, quantity: 89.25 mg; potassium chloride, quantity: 23.3 mg - powder, oral - excipient ingredients: acesulfame potassium - for effective relief from constipation and treatment of chronic constipation in adults and children aged 2 years and older. for resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum, or the rectum and colon, confirmed by physical examination of abdomen and rectum, in adults and children 2 years and older. for prevention of recurrence of faecal impaction in children aged 2 years and older. use in children 2 years and older should be limited to 12 weeks except under medical supervision.