Detailed SMPC and OD register data for: Ocaliva
Data as extracted from Orphan Designation Register
Product (OD)
Ocaliva
PL number (OD)
PLGB 48025/0004
OD Designation ID (OD)
OD1
Active substance (OD)
obeticholic acid 6alpha-ethyl-chenodeoxycholic acid
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.
SMPC composition / active substance
Matched EMA substance
EMA SMS ID
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
Ocaliva is indicated for the treatment of primary biliary cholangitis (PCB) (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.
Full Designation Number(OD)
PLGB 48025/0004-0005/OD1
Orphan Condition(OD)
Primary biliary cirrhosis
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
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