EMA recommends revoking conditional marketing authorisation for Ocaliva

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Summary

EMA recommends revoking the conditional marketing authorisation for Ocaliva (obeticholic acid) after concluding that its benefits no longer outweigh its risks. …

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Diseases / indications

• Biliary Cholangitis

Drugs mentioned

• Ocaliva (obeticholic acid)

Snippet

Benefits of Ocaliva no longer considered to outweigh its risks