Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - ursodeoxycholic acid - hard capsule - ursodeoxycholic acid 250 mg - bile and liver therapy

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - ursodeoxycholic acid - tablet - ursodeoxycholic acid 150 mg - bile and liver therapy

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

dr falk pharma australia pty ltd - ursodeoxycholic acid, quantity: 50 mg/ml - oral liquid, suspension - excipient ingredients: purified water; sodium cyclamate; citric acid; sodium citrate dihydrate; xylitol; sodium chloride; glycerol; propylene glycol; benzoic acid; microcrystalline cellulose; carmellose sodium; flavour - treatment of chronic cholestatic liver diseases.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - ursodeoxycholic acid - white tablet with split line, diameter: 8.0mm, thickness: 2.7mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

towa pharmaceutical co., ltd. - ursodeoxycholic acid - white tablet, diameter: 6.0mm, thickness: 2.9mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

sawai pharmaceutical co.,ltd. - ursodeoxycholic acid - white tablet, diameter: 8.0 mm, thickness: 2.8 mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nihon generic co.,ltd - ursodeoxycholic acid - white tablet, diameter 8.0mm, thickness 2.7mm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

nihon generic co.,ltd - ursodeoxycholic acid - white tablet, diameter 6.0mm, thickness 2.4mm

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

Ireland - English - HPRA (Health Products Regulatory Authority)

dr. falk pharma gmbh - ursodeoxycholic acid - oral suspension - 250 mg/5ml - bile acid preparations; ursodeoxycholic acid