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.

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

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

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

intercept pharma uk & ireland ltd - obeticholic acid - tablet - 10mg

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.

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

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