Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: ADVANZ PHARMA Limited, Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland
Ocaliva 5 mg film-coated tablets.
Ocaliva 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Ocaliva 5 mg film-coated tablets: Yellow, 8 mm round tablet debossed with ‘INT’ on one side and ‘5’ on the other side. Ocaliva 10 mg film-coated tablets: Yellow, 8 mm × 7 mm triangular tablet debossed with ‘INT’ on one side and ‘10’ on the other side. |
Ocaliva 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic acid.
Ocaliva 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of obeticholic acid.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Tablet coating: Poly(vinyl alcohol), partially hydrolysed (E1203) |
High-density polyethylene (HDPE) bottles with a child resistant polypropylene closure and an aluminium foil induction seal.
Pack size: 30 or 100 film-coated tablets.
Not all pack sizes may be marketed.
ADVANZ PHARMA Limited, Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland
EU/1/16/1139/001
EU/1/16/1139/002
EU/1/16/1139/003
EU/1/16/1139/004
Date of first authorisation: 12 December 2016
Date of latest renewal: 09 November 2022
| Drug | Countries | |
|---|---|---|
| OCALIVA | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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