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

Israel - English - Ministry of Health

neopharm ltd, israel - obeticholic acid - film coated tablets - obeticholic acid 10 mg - obeticholic acid - ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

Israel - English - Ministry of Health

neopharm ltd, israel - obeticholic acid - film coated tablets - obeticholic acid 5 mg - obeticholic acid - ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

Kenya - English - Pharmacy and Poisons Board

beacon medicare limited 9/b/2, toyenbee circular road, motijheel, - obeticholic acid inn - tablet - obeticholic acid 5mg - obeticholic acid

European Union - English - EMA (European Medicines Agency)

advanz pharma limited - obeticholic acid - liver cirrhosis, biliary - bile and liver therapy - ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

Canada - English - Health Canada

advanz pharma canada inc. - obeticholic acid - tablet - 5mg - obeticholic acid 5mg - miscellaneous gi drugs

Canada - English - Health Canada

advanz pharma canada inc. - obeticholic acid - tablet - 10mg - obeticholic acid 10mg - miscellaneous gi drugs

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

chiesi australia pty ltd - obeticholic acid, quantity: 5 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - ocaliva is indicated for the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

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

chiesi australia pty ltd - obeticholic acid, quantity: 10 mg - tablet - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - ocaliva is indicated for the treatment of primary biliary cholangitis (pbc) in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca.

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

intercept pharma uk & ireland ltd - obeticholic acid - tablet - 5mg