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) - New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation

Key facts

• Medicine name:
  Ocaliva
• Active substance:
  Obeticholic acid
• Therapeutic area (MeSH):
  Liver Cirrhosis, Biliary
• Procedure number:
  EMEA/H/C/004093/II/0030
• Regulatory outcome:
  Variation
• DHPC type:
  New contraindication
• Human ATC codes:
  A05AA04
• Dissemination date:
  09/06/2022