EMA Revoked: Ocaliva (obeticholic acid) — Advanz Pharma Limited

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Summary

EMA revoked the marketing authorization for Ocaliva (obeticholic acid) held by Advanz Pharma Limited, effective 16 April 2024, for biliary/liver disease indicat…

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Diseases / indications

• Biliary Cholangitis
• Liver Cirrhosis

Drugs mentioned

• Ocaliva (obeticholic acid)

Snippet

Status: Revoked. Therapeutic area: Liver Cirrhosis, Biliary. MAH: Advanz Pharma Limited. Decision date: 16/04/2024. Conditional approval