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

arrotex pharmaceuticals pty ltd - ursodeoxycholic acid, quantity: 250 mg - capsule - excipient ingredients: titanium dioxide; maize starch; silicon dioxide; gelatin; magnesium stearate - ursodeoxycholic acid is indicated in the treatment of chronic cholestatic liver diseases.

European Union - English - EMA (European Medicines Agency)

leadiant gmbh - chenodeoxycholic acid - xanthomatosis, cerebrotendinous; metabolism, inborn errors - bile and liver therapy - chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (ctx)) in infants, children and adolescents aged 1 month to 18 years and adults.

Israel - English - Ministry of Health

mbi pharma ltd., israel - chenodeoxycholic acid - hard capsule - chenodeoxycholic acid 250 mg - chenodeoxycholic acid - the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (ctx)) in infants, children and adolescents aged 1 month to 18 years and adults.

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

intercept pharmaceuticals inc - obeticholic acid (unii: 0462z4s4oz) (obeticholic acid - unii:0462z4s4oz) - obeticholic acid 5 mg - ocaliva® is indicated for the treatment of adult patients with primary biliary cholangitis (pbc) - without cirrhosis or - with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (udca) with an inadequate response to udca or as monotherapy in patients unable to tolerate udca. this indication is approved under accelerated approval based on a reduction in alkaline phosphatase (alp) [see clinical studies (14)] . an improvement in survival or disease-related symptoms has not been established. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. ocaliva is contraindicated in patients with: - decompensated cirrhosis (e.g., child-pugh class b or c) or a prior decompensation event [see warnings and precautions (5.1)] . - compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) [see warnings and

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

generic health pty ltd - ursodeoxycholic acid, quantity: 250 mg - capsule, hard - excipient ingredients: magnesium stearate; colloidal anhydrous silica; maize starch; titanium dioxide; iron oxide yellow; gelatin - ursodox gh (ursodeoxycholic acid) capsule is indicated in the treatment of chronic cholestatic liver diseases.

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

abbvie pty ltd - deoxycholic acid, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; hydrochloric acid - belkyra (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults

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

galen ltd - ursodeoxycholic acid - oral capsule - 250mg

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

kythera biopharmaceuticals inc. - deoxycholic acid (unii: 005990whzz) (deoxycholic acid - unii:005990whzz) - deoxycholic acid 20 mg in 2 ml - kybella® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. limitations of use the safe and effective use of kybella for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. kybella injection is contraindicated in the presence of infection at the injection sites. risk summary there are no adequate and well-controlled studies of kybella injection in pregnant women to inform the drug-associated risk. in animal reproduction studies, no fetal harm was observed with the subcutaneous administration of deoxycholic acid to rats during organogenesis at doses up to 5 times the maximum recommended human dose (mrhd) of 100 mg [see data] .  the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk of major birth defects in the u.s. general population is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.  data animal data embryofetal development studies have been performed in rats and rabbits using subcutaneous doses of deoxycholic acid administered during the period of organogenesis. for the basis of comparing animal to human doses, the mrhd is 1.7 mg/kg (100 mg/60 kg). no evidence of fetal harm was observed in rats at up to the highest dose tested (50 mg/kg) which is 5-fold higher than the mrhd of kybella based on a mg/m2 comparison. however, missing intermediate lung lobe was noted in rabbits at all dose levels tested including the lowest dose (10 mg/kg) which is 2-fold higher than the mrhd of kybella based on a mg/m2 comparison. these effects may be related to maternal toxicity, which was also seen at all dose levels tested.   risk summary there is no information available on the presence of synthetic deoxycholic acid in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for kybella and any potential adverse effects on the breastfed child from kybella or from the underlying maternal condition. safety and effectiveness in patients below the age of 18 years have not been established and kybella is not intended for use in children or adolescents. the clinical trials of kybella did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

a a h pharmaceuticals ltd - ursodeoxycholic acid - oral capsule - 250mg

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

alliance healthcare (distribution) ltd - ursodeoxycholic acid - oral capsule - 250mg