Ocaliva

Revoked

This medicine's authorisation has been revoked

obeticholic acid

Overview

The marketing authorisation of Ocaliva was revoked by the Commission Implementing Decision of 30 August 2024.

Ocaliva : EPAR - Summary for the public

Ocaliva : EPAR - Risk management plan summary

Product information

Ocaliva : EPAR - Product Information

Ocaliva : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ocaliva
• Active substance:
  obeticholic acid
• International non-proprietary name (INN) or common name:
  obeticholic acid
• Therapeutic area (MeSH):
  Liver Cirrhosis, Biliary
• Anatomical therapeutic chemical (ATC) code:
  A05AA04

Pharmacotherapeutic group

Bile and liver therapy

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.

Authorisation details

• EMA product number:
  EMEA/H/C/004093
• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation holder:
  Advanz Pharma Limited

  Unit 17; Northwood House; Northwood Crescent; Dublin 9; D09 V504; Ireland

• Opinion adopted:
  13/10/2016
• Marketing authorisation issued:
  12/12/2016
• Revocation of marketing authorisation:
  30/08/2024
• Revision:
  21

Assessment history

Changes since initial authorisation of medicine

Ocaliva : EPAR - Procedural steps taken and scientific information after authorisation

Ocaliva-H-C-004093-II-0038 : EPAR - Refusal assessment report - variation

Adopted Reference Number: EMA/528620/2023

Ocaliva-H-C-PSUSA-00010555-201706 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/289133/2018

Ocaliva : EPAR - Conclusions on the granting of the conditional marketing authorisation

Initial marketing authorisation documents

Ocaliva : EPAR - Public assessment report

Adopted Reference Number: EMA/725757/2016

CHMP summary of positive opinion for Ocaliva

Adopted Reference Number: EMA/CHMP/651446/2016