OCALIVA

This brand name is authorized in Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States

Active ingredients

The drug OCALIVA contains one active pharmaceutical ingredient (API):

1 Obeticholic acid UNII 0462Z4S4OZ - OBETICHOLIC ACID

Obeticholic acid is a selective and potent agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed at high levels in the liver and intestine. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol, as well as, by increasing transport of bile acids out of the hepatocytes. Read about Obeticholic acid

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
OCALIVA Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A05AA04		A Alimentary tract and metabolism → A05 Bile and liver therapy → A05A Bile therapy → A05AA Bile acid preparations
Discover more medicines within A05AA04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02463121, 02463148
Country: EE	Ravimiamet	Identifier(s): 1734836, 1734847, 1757145, 1757156
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1161139001, 1161139002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 373887, 405200
Country: FR	Base de données publique des médicaments	Identifier(s): 61233389, 69761794
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 340010, 340014
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8462, 8469
Country: IT	Agenzia del Farmaco	Identifier(s): 045222015, 045222027, 045222039, 045222041
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1081844, 1081845, 1084583, 1084584
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100382004, 100382010
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68841001, W68842001
Country: US	FDA, National Drug Code	Identifier(s): 69516-005, 69516-010