Ocaliva - direct healthcare professional communication (DHPC)

Obeticholic acid

About

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

Documents

Direct healthcare professional communication (DHPC) : Ocaliva (obeticholic acid): recommendation for revocation of the marketing authorisation in the European Union due to unconfirmed clinical benefit

Dissemination date: 31/07/2024

Key facts

• Medicine name:
  Ocaliva
• Active substance:
  Obeticholic acid
• Therapeutic area (MeSH):
  Liver Cirrhosis, Biliary
• Regulatory outcome:
  Revocation
• DHPC type:
  Post-authorisation measure
• Human ATC codes:
  A05AA04
• Dissemination date:
  31/07/2024