Ocaliva

Unknown🇪🇺 European Union

EMA Page

Authorised Date: N/A
Approval ID: afab5ba33fb08f13
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

The marketing authorisation of Ocaliva was revoked by the Commission Implementing Decision of 30 August 2024\.

Therapeutic & Classification

Therapeutic Indication

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.

Therapeutic Area (MeSH)

Liver Cirrhosis, Biliary

ATC Code

A05AA04

ATC Item

N/A

Pharmacotherapeutic Group

Bile and liver therapy

Active Substances

Active Substance (Summary)

obeticholic acid

INN / Common Names

obeticholic acid

Active Substance Details

Active substance details are not yet available.

Quick Info

Approval IDafab5ba33fb08f13

Product NumberN/A

StatusAuthorised

Authorised DateN/A

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Ocaliva

Medicine Name

Ocaliva

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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