OCALIVA

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

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 more about Obeticholic acid

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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